Surgical sealing systems for instrument stabilization

ABSTRACT

Surgical sealing systems are provided. In one exemplary embodiment, a surgical sealing system includes a seal housing having a plurality of ports, in which each of port has a nominal size and shape, is configured to assume a selected and/or shape that is different from the nominal size and shape, and is constrained by the size and shape of each of the other plurality of ports. The position of an instrument and a force applied thereto is effective to change the size and/or shape of the ports based on the movement, direction, and force of the instrument, and the ability to alter the nominal shape of any one port is constrained or limited by the size and shape of the other ports, thereby enabling a force applied to one instrument positioned within one of the plurality of ports to stabilize at least one other instrument positioned within others of the plurality of ports.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 63/249,980 filed on Sep. 29, 2021, and entitled “CooperativeAccess,” the disclosure of which is incorporated herein by reference inits entirety.

FIELD

The present invention relates generally to surgical devices, systems,and methods of using the same for sealing, instrument control,instrument stabilization, etc.

BACKGROUND

Surgical systems often incorporate an imaging system, which can allowmedical practitioners to view a surgical site and/or one or moreportions thereof on one or more displays, (e.g., a monitor, a computertablet screen, etc.). The display(s) can be local and/or remote to asurgical theater. The imaging system can include a scope with a camerathat views the surgical site and transmits the view to the one or moredisplays viewable by medical practitioner(s).

Imaging systems can be limited by the information that they are able torecognize and/or convey to the medical practitioner(s). For example,certain concealed structures, physical contours, and/or dimensionswithin a three-dimensional space may be unrecognizable intraoperativelyby certain imaging systems. For another example, certain imaging systemsmay be incapable of communicating and/or conveying certain informationto the medical practitioner(s) intraoperatively.

Accordingly, there remains a need for improved surgical imaging.

SUMMARY

Surgical sealing systems are provided. In one exemplary embodiment, thesealing system includes a sealing device having a seal housing with apredetermined size and shape. The seal housing is configured to be atleast partially disposed within a body cavity and has a plurality ofports. Each of the plurality of ports has a nominal size and shape andeach is configured to assume a selected size and/or shape that isdifferent from the nominal size and/or shape. The selected size and/orshape of each port being constrained by the size and shape of each ofthe other plurality of ports, Each of the plurality of ports isconfigured to form a seal around an instrument inserted therethrough.The position of an instrument that is positioned within one port of theplurality of ports and a force applied thereto is effective to changethe size and/or shape of the ports based on the movement, direction, andforce of the instrument, and the ability to alter the nominal shape ofany one port is constrained or limited by the size and/or shape of theother ports, thereby enabling a force applied to one instrumentpositioned within one of the plurality of ports to stabilize at leastone other instrument positioned within others of the plurality of ports.

In some embodiments, the surgical sealing system can include at leastone electromechanical arm, in which at least one instrument that isinserted into a respective port of the plurality of ports can beconnected to the at least one electromechanical arm.

The surgical sealing device can have a variety of configurations. Insome embodiments, the sealing device can include a retractor that can becoupled to the seal housing and can be configured to be positioned in anatural body orifice or an opening formed in tissue. In otherembodiments, the sealing device can include at least one retentionelement that can be configured to affix the seal housing to tissue.

The plurality of ports can have a variety of configurations. In someembodiments, a first port of the plurality of ports can be configured toapply a first force to a first instrument that is inserted therethroughto thereby limit movement thereof within a first plane, and a secondport of the plurality of ports can be configured to apply a second forceto a second instrument that is inserted therethrough to thereby limitmovement thereof within a second plane, the second plane beingnon-parallel to the first plane. In certain embodiments, one or moreports of the plurality of ports can be rigid relative to one or moreother ports of the plurality of ports.

In some embodiments, at least one port of the plurality of ports caninclude a threaded restraint configured to fixate an instrument insertedtherethrough. In other embodiments, at least one port of the pluralityof ports can be configured to change shape and size in response toexternal energy being applied thereto.

In some embodiments, at least one port of the plurality of ports can beformed of a ferromagnetic material that can be configured to bestructurally altered in response to exposure to an electromagnet. Inother embodiments, at least one port of the plurality of ports caninclude a locking arm arranged within a slot of the seal housing, thelocking arm can be configured to lock a position of the at least oneport relative to the seal housing.

In some embodiments, at least one port of the plurality of ports caninclude a locking structure that can be configured to interact andcollapse around an instrument passing therethrough to fixate theinserted instrument within the at least one port. In one embodiment, thelocking structure can have a honeycomb configuration.

In some embodiments, a first instrument and a second instrument that canbe inserted into respective ports of the plurality of ports can bestabilized simultaneously by a central anchoring tool that can beconfigured to be inserted through a port of the plurality of ports.

The surgical housing can have a variety of configurations. In someembodiments, the sealing housing can include a flexible inner bodymember and a rigid outer body member, wherein each port of the pluralityof ports can be arranged within the inner body member. In oneembodiment, at least one port of the plurality of ports can include arigid ring encapsulated by the flexible inner body member.

BRIEF DESCRIPTION OF DRAWINGS

The present invention is described by way of reference to theaccompanying figures which are as follows:

FIG. 1 is a schematic view of one embodiment of a surgical visualizationsystem;

FIG. 2 is a schematic view of triangularization between a surgicaldevice, an imaging device, and a critical structure of FIG. 1 ;

FIG. 3 is a schematic view of another embodiment of a surgicalvisualization system;

FIG. 4 is a schematic view of one embodiment of a control system for asurgical visualization system;

FIG. 5 is a schematic view of one embodiment of a control circuit of acontrol system for a surgical visualization system;

FIG. 6 is a schematic view of one embodiment of a combinational logiccircuit of a surgical visualization system;

FIG. 7 is a schematic view of one embodiment of a sequential logiccircuit of a surgical visualization system;

FIG. 8 is a schematic view of yet another embodiment of a surgicalvisualization system;

FIG. 9 is a schematic view of another embodiment of a control system fora surgical visualization system;

FIG. 10 is a graph showing wavelength versus absorption coefficient forvarious biological materials;

FIG. 11 is a schematic view of one embodiment of a spectral emittervisualizing a surgical site;

FIG. 12 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate a ureter from obscurants;

FIG. 13 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate an artery from obscurants;

FIG. 14 is a graph depicting illustrative hyperspectral identifyingsignatures to differentiate a nerve from obscurants;

FIG. 15 is a schematic view of one embodiment of a near infrared (NIR)time-of-flight measurement system being utilized intraoperatively;

FIG. 16 shows a time-of-flight timing diagram for the system of FIG. 15;

FIG. 17 is a schematic view of another embodiment of a near infrared(NIR) time-of-flight measurement system being utilized intraoperatively;

FIG. 18 is a schematic view of one embodiment of a computer-implementedinteractive surgical system;

FIG. 19 is a schematic view of one embodiment a surgical system beingused to perform a surgical procedure in an operating room;

FIG. 20 is a schematic view of one embodiment of a surgical systemincluding a smart surgical instrument and a surgical hub;

FIG. 21 is a flowchart showing a method of controlling the smartsurgical instrument of FIG. 20 ;

FIG. 22 is a schematic view of an exemplary embodiment of a surgicalsealing device;

FIG. 23 is a cross-sectional view of the surgical sealing device of FIG.22 ;

FIG. 24 is a cross-sectional view of another exemplary embodiment of asurgical sealing device;

FIG. 25 is a cross-sectional view of another exemplary embodiment of asurgical sealing device, showing the device inserted into a natural bodyorifice;

FIG. 26 is an exemplary image of a colon;

FIG. 27 is a schematic view of an exemplary embodiment of a surgicalsystem having first and second multi-port devices;

FIG. 28 is a schematic view of the surgical system of FIG. 27 , showingthe first and second multi-port devices partially inserted within anabdominal cavity;

FIG. 29 is a schematic view of an exemplary embodiment of a surgicalsealing system having a sealing device with ports extendingtherethrough;

FIG. 30 is a top view of the sealing device of FIG. 29 ;

FIG. 31 is a schematic view of the ports of the surgical sealing port ofFIG. 29 ;

FIG. 32 is a schematic view of the altered ports of the surgical sealingport of FIG. 31 ;

FIG. 33 is the sealing device of FIG. 29 , showing an instrumentinserted into one port of the sealing device;

FIG. 34 is a schematic view of an exemplary embodiment of a surgicalsealing system having threaded restraints;

FIG. 35 is a schematic of an exemplary embodiment of a surgical roboticsystem that includes electomechanical arms each having a surgicalinstrument mounted thereto, and being wirelessly coupled to a controlsystem;

FIG. 36 is schematic view of an embodiment of a locking arm; and

FIG. 37 is a schematic view of one embodiment of a locking structureprior to exposure to external energy; and

FIG. 38 is the locking structure of FIG. 37 after exposure to externalenergy.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices, systems, and methods disclosedherein. One or more examples of these embodiments are illustrated in theaccompanying drawings. A person skilled in the art will understand thatthe devices, systems, and methods specifically described herein andillustrated in the accompanying drawings are non-limiting exemplaryembodiments and that the scope of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Further, in the present disclosure, like-named components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-named component is notnecessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. A person skilled inthe art will appreciate that a dimension may not be a precise value butnevertheless be considered to be at about that value due to any numberof factors such as manufacturing tolerances and sensitivity ofmeasurement equipment. Sizes and shapes of the systems and devices, andthe components thereof, can depend at least on the size and shape ofcomponents with which the systems and devices will be used.

Surgical Visualization

In general, a surgical visualization system is configured to leverage“digital surgery” to obtain additional information about a patient'sanatomy and/or a surgical procedure. The surgical visualization systemis further configured to convey data to one or more medicalpractitioners in a helpful manner. Various aspects of the presentdisclosure provide improved visualization of the patient's anatomyand/or the surgical procedure, and/or use visualization to provideimproved control of a surgical tool (also referred to herein as a“surgical device” or a “surgical instrument”).

“Digital surgery” can embrace robotic systems, advanced imaging,advanced instrumentation, artificial intelligence, machine learning,data analytics for performance tracking and benchmarking, connectivityboth inside and outside of the operating room (OR), and more. Althoughvarious surgical visualization systems described herein can be used incombination with a robotic surgical system, surgical visualizationsystems are not limited to use with a robotic surgical system. Incertain instances, surgical visualization using a surgical visualizationsystem can occur without robotics and/or with limited and/or optionalrobotic assistance. Similarly, digital surgery can occur withoutrobotics and/or with limited and/or optional robotic assistance.

In certain instances, a surgical system that incorporates a surgicalvisualization system may enable smart dissection in order to identifyand avoid critical structures. Critical structures include anatomicalstructures such as a ureter, an artery such as a superior mesentericartery, a vein such as a portal vein, a nerve such as a phrenic nerve,and/or a tumor, among other anatomical structures. In other instances, acritical structure can be a foreign structure in the anatomical field,such as a surgical device, a surgical fastener, a clip, a tack, abougie, a band, a plate, and other foreign structures. Criticalstructures can be determined on a patient-by-patient and/or aprocedure-by-procedure basis. Smart dissection technology may provide,for example, improved intraoperative guidance for dissection and/or mayenable smarter decisions with critical anatomy detection and avoidancetechnology.

A surgical system incorporating a surgical visualization system mayenable smart anastomosis technologies that provide more consistentanastomoses at optimal location(s) with improved workflow. Cancerlocalization technologies may be improved with a surgical visualizationplatform. For example, cancer localization technologies can identify andtrack a cancer location, orientation, and its margins. In certaininstances, the cancer localization technologies may compensate formovement of a surgical instrument, a patient, and/or the patient'sanatomy during a surgical procedure in order to provide guidance back tothe point of interest for medical practitioner(s).

A surgical visualization system may provide improved tissuecharacterization and/or lymph node diagnostics and mapping. For example,tissue characterization technologies may characterize tissue type andhealth without the need for physical haptics, especially when dissectingand/or placing stapling devices within the tissue. Certain tissuecharacterization technologies may be utilized without ionizing radiationand/or contrast agents. With respect to lymph node diagnostics andmapping, a surgical visualization platform may, for example,preoperatively locate, map, and ideally diagnose the lymph system and/orlymph nodes involved in cancerous diagnosis and staging.

During a surgical procedure, information available to a medicalpractitioner via the “naked eye” and/or an imaging system may provide anincomplete view of the surgical site. For example, certain structures,such as structures embedded or buried within an organ, can be at leastpartially concealed or hidden from view. Additionally, certaindimensions and/or relative distances can be difficult to ascertain withexisting sensor systems and/or difficult for the “naked eye” toperceive. Moreover, certain structures can move pre-operatively (e.g.,before a surgical procedure but after a preoperative scan) and/orintraoperatively. In such instances, the medical practitioner can beunable to accurately determine the location of a critical structureintraoperatively.

When the position of a critical structure is uncertain and/or when theproximity between the critical structure and a surgical tool is unknown,a medical practitioner's decision-making process can be inhibited. Forexample, a medical practitioner may avoid certain areas in order toavoid inadvertent dissection of a critical structure; however, theavoided area may be unnecessarily large and/or at least partiallymisplaced. Due to uncertainty and/or overly/excessive exercises incaution, the medical practitioner may not access certain desiredregions. For example, excess caution may cause a medical practitioner toleave a portion of a tumor and/or other undesirable tissue in an effortto avoid a critical structure even if the critical structure is not inthe particular area and/or would not be negatively impacted by themedical practitioner working in that particular area. In certaininstances, surgical results can be improved with increased knowledgeand/or certainty, which can allow a surgeon to be more accurate and, incertain instances, less conservative/more aggressive with respect toparticular anatomical areas.

A surgical visualization system can allow for intraoperativeidentification and avoidance of critical structures. The surgicalvisualization system may thus enable enhanced intraoperative decisionmaking and improved surgical outcomes. The surgical visualization systemcan provide advanced visualization capabilities beyond what a medicalpractitioner sees with the “naked eye” and/or beyond what an imagingsystem can recognize and/or convey to the medical practitioner. Thesurgical visualization system can augment and enhance what a medicalpractitioner is able to know prior to tissue treatment (e.g.,dissection, etc.) and, thus, may improve outcomes in various instances.As a result, the medical practitioner can confidently maintain momentumthroughout the surgical procedure knowing that the surgicalvisualization system is tracking a critical structure, which may beapproached during dissection, for example. The surgical visualizationsystem can provide an indication to the medical practitioner insufficient time for the medical practitioner to pause and/or slow downthe surgical procedure and evaluate the proximity to the criticalstructure to prevent inadvertent damage thereto. The surgicalvisualization system can provide an ideal, optimized, and/orcustomizable amount of information to the medical practitioner to allowthe medical practitioner to move confidently and/or quickly throughtissue while avoiding inadvertent damage to healthy tissue and/orcritical structure(s) and, thus, to minimize the risk of harm resultingfrom the surgical procedure.

Surgical visualization systems are described in detail below. Ingeneral, a surgical visualization system can include a first lightemitter configured to emit a plurality of spectral waves, a second lightemitter configured to emit a light pattern, and a receiver, or sensor,configured to detect visible light, molecular responses to the spectralwaves (spectral imaging), and/or the light pattern. The surgicalvisualization system can also include an imaging system and a controlcircuit in signal communication with the receiver and the imagingsystem. Based on output from the receiver, the control circuit candetermine a geometric surface map, e.g., three-dimensional surfacetopography, of the visible surfaces at the surgical site and a distancewith respect to the surgical site, such as a distance to an at leastpartially concealed structure. The imaging system can convey thegeometric surface map and the distance to a medical practitioner. Insuch instances, an augmented view of the surgical site provided to themedical practitioner can provide a representation of the concealedstructure within the relevant context of the surgical site. For example,the imaging system can virtually augment the concealed structure on thegeometric surface map of the concealing and/or obstructing tissuesimilar to a line drawn on the ground to indicate a utility line belowthe surface. Additionally or alternatively, the imaging system canconvey the proximity of a surgical tool to the visible and obstructingtissue and/or to the at least partially concealed structure and/or adepth of the concealed structure below the visible surface of theobstructing tissue. For example, the visualization system can determinea distance with respect to the augmented line on the surface of thevisible tissue and convey the distance to the imaging system.

Throughout the present disclosure, any reference to “light,” unlessspecifically in reference to visible light, can include electromagneticradiation (EMR) or photons in the visible and/or non-visible portions ofthe EMR wavelength spectrum. The visible spectrum, sometimes referred toas the optical spectrum or luminous spectrum, is that portion of theelectromagnetic spectrum that is visible to (e.g., can be detected by)the human eye and may be referred to as “visible light” or simply“light.” A typical human eye will respond to wavelengths in air that arefrom about 380 nm to about 750 nm. The invisible spectrum (e.g., thenon-luminous spectrum) is that portion of the electromagnetic spectrumthat lies below and above the visible spectrum . The invisible spectrumis not detectable by the human eye. Wavelengths greater than about 750nm are longer than the red visible spectrum, and they become invisibleinfrared (IR), microwave, and radio electromagnetic radiation.Wavelengths less than about 380 nm are shorter than the violet spectrum,and they become invisible ultraviolet, x-ray, and gamma rayelectromagnetic radiation.

FIG. 1 illustrates one embodiment of a surgical visualization system100. The surgical visualization system 100 is configured to create avisual representation of a critical structure 101 within an anatomicalfield. The critical structure 101 can include a single criticalstructure or a plurality of critical structures. As discussed herein,the critical structure 101 can be any of a variety of structures, suchas an anatomical structure, e.g., a ureter, an artery such as a superiormesenteric artery, a vein such as a portal vein, a nerve such as aphrenic nerve, a vessel, a tumor, or other anatomical structure, or aforeign structure, e.g., a surgical device, a surgical fastener, asurgical clip, a surgical tack, a bougie, a surgical band, a surgicalplate, or other foreign structure. As discussed herein, the criticalstructure 101 can be identified on a patient-by-patient and/or aprocedure-by-procedure basis. Embodiments of critical structures and ofidentifying critical structures using a visualization system are furtherdescribed in U.S. Pat. No. 10,792,034 entitled “Visualization OfSurgical Devices” issued Oct. 6, 2020, which is hereby incorporated byreference in its entirety.

In some instances, the critical structure 101 can be embedded in tissue103. The tissue 103 can be any of a variety of tissues, such as fat,connective tissue, adhesions, and/or organs. Stated differently, thecritical structure 101 may be positioned below a surface 105 of thetissue 103. In such instances, the tissue 103 conceals the criticalstructure 101 from the medical practitioner's “naked eye” view. Thetissue 103 also obscures the critical structure 101 from the view of animaging device 120 of the surgical visualization system 100. Instead ofbeing fully obscured, the critical structure 101 can be partiallyobscured from the view of the medical practitioner and/or the imagingdevice 120.

The surgical visualization system 100 can be used for clinical analysisand/or medical intervention. In certain instances, the surgicalvisualization system 100 can be used intraoperatively to providereal-time information to the medical practitioner during a surgicalprocedure, such as real-time information regarding proximity data,dimensions, and/or distances. A person skilled in the art willappreciate that information may not be precisely real time butnevertheless be considered to be real time for any of a variety ofreasons, such as time delay induced by data transmission, time delayinduced by data processing, and/or sensitivity of measurement equipment.The surgical visualization system 100 is configured for intraoperativeidentification of critical structure(s) and/or to facilitate theavoidance of the critical structure(s) 101 by a surgical device. Forexample, by identifying the critical structure 101, a medicalpractitioner can avoid maneuvering a surgical device around the criticalstructure 101 and/or a region in a predefined proximity of the criticalstructure 101 during a surgical procedure. For another example, byidentifying the critical structure 101, a medical practitioner can avoiddissection of and/or near the critical structure 101, thereby helping toprevent damage to the critical structure 101 and/or helping to prevent asurgical device being used by the medical practitioner from beingdamaged by the critical structure 101.

The surgical visualization system 100 is configured to incorporatetissue identification and geometric surface mapping in combination withthe surgical visualization system's distance sensor system 104. Incombination, these features of the surgical visualization system 100 candetermine a position of a critical structure 101 within the anatomicalfield and/or the proximity of a surgical device 102 to the surface 105of visible tissue 103 and/or to the critical structure 101. Moreover,the surgical visualization system 100 includes an imaging system thatincludes the imaging device 120 configured to provide real-time views ofthe surgical site. The imaging device 120 can include, for example, aspectral camera (e.g., a hyperspectral camera, multispectral camera, orselective spectral camera), which is configured to detect reflectedspectral waveforms and generate a spectral cube of images based on themolecular response to the different wavelengths. Views from the imagingdevice 120 can be provided in real time to a medical practitioner, suchas on a display (e.g., a monitor, a computer tablet screen, etc.). Thedisplayed views can be augmented with additional information based onthe tissue identification, landscape mapping, and the distance sensorsystem 104. In such instances, the surgical visualization system 100includes a plurality of subsystems—an imaging subsystem, a surfacemapping subsystem, a tissue identification subsystem, and/or a distancedetermining subsystem. These subsystems can cooperate tointra-operatively provide advanced data synthesis and integratedinformation to the medical practitioner.

The imaging device 120 can be configured to detect visible light,spectral light waves (visible or invisible), and a structured lightpattern (visible or invisible). Examples of the imaging device 120includes scopes, e.g., an endoscope, an arthroscope, an angioscope, abronchoscope, a choledochoscope, a colonoscope, a cytoscope, aduodenoscope, an enteroscope, an esophagogastro-duodenoscope(gastroscope), a laryngoscope, a nasopharyngo-neproscope, asigmoidoscope, a thoracoscope, an ureteroscope, or an exoscope. Scopescan be particularly useful in minimally invasive surgical procedures. Inopen surgery applications, the imaging device 120 may not include ascope.

The tissue identification subsystem can be achieved with a spectralimaging system. The spectral imaging system can rely on imaging such ashyperspectral imaging, multispectral imaging, or selective spectralimaging. Embodiments of hyperspectral imaging of tissue are furtherdescribed in U.S. Pat. No. 9,274,047 entitled “System And Method ForGross Anatomic Pathology Using Hyperspectral Imaging” issued Mar. 1,2016, which is hereby incorporated by reference in its entirety.

The surface mapping subsystem can be achieved with a light patternsystem. Various surface mapping techniques using a light pattern (orstructured light) for surface mapping can be utilized in the surgicalvisualization systems described herein. Structured light is the processof projecting a known pattern (often a grid or horizontal bars) on to asurface. In certain instances, invisible (or imperceptible) structuredlight can be utilized, in which the structured light is used withoutinterfering with other computer vision tasks for which the projectedpattern may be confusing. For example, infrared light or extremely fastframe rates of visible light that alternate between two exact oppositepatterns can be utilized to prevent interference. Embodiments of surfacemapping and a surgical system including a light source and a projectorfor projecting a light pattern are further described in U.S. Pat. Pub.No. 2017/0055819 entitled “Set Comprising A Surgical Instrument”published Mar. 2, 2017, U.S. Pat. Pub. No. 2017/0251900 entitled“Depiction System” published Sep. 7, 2017, and U.S. patent applicationSer. No. 16/729,751 entitled “Surgical Systems For Generating ThreeDimensional Constructs Of Anatomical Organs And Coupling IdentifiedAnatomical Structures Thereto” filed Dec. 30, 2019, which are herebyincorporated by reference in their entireties.

The distance determining system can be incorporated into the surfacemapping system. For example, structured light can be utilized togenerate a three-dimensional (3D) virtual model of the visible surface105 and determine various distances with respect to the visible surface105. Additionally or alternatively, the distance determining system canrely on time-of-flight measurements to determine one or more distancesto the identified tissue (or other structures) at the surgical site.

The surgical visualization system 100 also includes a surgical device102. The surgical device 102 can be any suitable surgical device.Examples of the surgical device 102 includes a surgical dissector, asurgical stapler, a surgical grasper, a clip applier, a smoke evacuator,a surgical energy device (e.g., mono-polar probes, bi-polar probes,ablation probes, an ultrasound device, an ultrasonic end effector,etc.), etc. In some embodiments, the surgical device 102 includes an endeffector having opposing jaws that extend from a distal end of a shaftof the surgical device 102 and that are configured to engage tissuetherebetween.

The surgical visualization system 100 can be configured to identify thecritical structure 101 and a proximity of the surgical device 102 to thecritical structure 101. The imaging device 120 of the surgicalvisualization system 100 is configured to detect light at variouswavelengths, such as visible light, spectral light waves (visible orinvisible), and a structured light pattern (visible or invisible). Theimaging device 120 can include a plurality of lenses, sensors, and/orreceivers for detecting the different signals. For example, the imagingdevice 120 can be a hyperspectral, multispectral, or selective spectralcamera, as described herein. The imaging device 120 can include awaveform sensor 122 (such as a spectral image sensor, detector, and/orthree-dimensional camera lens). For example, the imaging device 120 caninclude a right-side lens and a left-side lens used together to recordtwo two-dimensional images at the same time and, thus, generate athree-dimensional (3D) image of the surgical site, render athree-dimensional image of the surgical site, and/or determine one ormore distances at the surgical site. Additionally or alternatively, theimaging device 120 can be configured to receive images indicative of thetopography of the visible tissue and the identification and position ofhidden critical structures, as further described herein. For example, afield of view of the imaging device 120 can overlap with a pattern oflight (structured light) on the surface 105 of the tissue 103, as shownin FIG. 1 .

As in this illustrated embodiment, the surgical visualization system 100can be incorporated into a robotic surgical system 110. The roboticsurgical system 110 can have a variety of configurations, as discussedherein. In this illustrated embodiment, the robotic surgical system 110includes a first robotic arm 112 and a second robotic arm 114. Therobotic arms 112, 114 each include rigid structural members 116 andjoints 118, which can include servomotor controls. The first robotic arm112 is configured to maneuver the surgical device 102, and the secondrobotic arm 114 is configured to maneuver the imaging device 120. Arobotic control unit of the robotic surgical system 110 is configured toissue control motions to the first and second robotic arms 112, 114,which can affect the surgical device 102 and the imaging device 120,respectively.

In some embodiments, one or more of the robotic arms 112, 114 can beseparate from the main robotic system 110 used in the surgicalprocedure. For example, at least one of the robotic arms 112, 114 can bepositioned and registered to a particular coordinate system without aservomotor control. For example, a closed-loop control system and/or aplurality of sensors for the robotic arms 112, 114 can control and/orregister the position of the robotic arm(s) 112, 114 relative to theparticular coordinate system. Similarly, the position of the surgicaldevice 102 and the imaging device 120 can be registered relative to aparticular coordinate system.

Examples of robotic surgical systems include the Ottava™robotic-assisted surgery system (Johnson & Johnson of New Brunswick,N.J.), da Vinci® surgical systems (Intuitive Surgical, Inc. ofSunnyvale, Calif.), the Hugo™ robotic-assisted surgery system (MedtronicPLC of Minneapolis, Minn.), the Versius® surgical robotic system (CMRSurgical Ltd of Cambridge, UK), and the Monarch® platform (Auris Health,Inc. of Redwood City, Calif.). Embodiments of various robotic surgicalsystems and using robotic surgical systems are further described in U.S.Pat. Pub. No. 2018/0177556 entitled “Flexible Instrument Insertion UsingAn Adaptive Force Threshold” filed Dec. 28, 2016, U.S. Pat. Pub. No.2020/0000530 entitled “Systems And Techniques For Providing MultiplePerspectives During Medical Procedures” filed Apr. 16, 2019, U.S. Pat.Pub. No. 2020/0170720 entitled “Image-Based Branch Detection And MappingFor Navigation” filed Feb. 7, 2020, U.S. Pat. Pub. No. 2020/0188043entitled “Surgical Robotics System” filed Dec. 9, 2019, U.S. Pat. Pub.No. 2020/0085516 entitled “Systems And Methods For Concomitant MedicalProcedures” filed Sep. 3, 2019, U.S. Pat. No. 8,831,782 entitled“Patient-Side Surgeon Interface For A Teleoperated Surgical Instrument”filed Jul. 15, 2013, and Intl. Pat. Pub. No. WO 2014151621 entitled“Hyperdexterous Surgical System” filed Mar. 13, 2014, which are herebyincorporated by reference in their entireties.

The surgical visualization system 100 also includes an emitter 106. Theemitter 106 is configured to emit a pattern of light, such as stripes,grid lines, and/or dots, to enable the determination of the topographyor landscape of the surface 105. For example, projected light arrays 130can be used for three-dimensional scanning and registration on thesurface 105. The projected light arrays 130 can be emitted from theemitter 106 located on the surgical device 102 and/or one of the roboticarms 112, 114 and/or the imaging device 120. In one aspect, theprojected light array 130 is employed by the surgical visualizationsystem 100 to determine the shape defined by the surface 105 of thetissue 103 and/or motion of the surface 105 intraoperatively. Theimaging device 120 is configured to detect the projected light arrays130 reflected from the surface 105 to determine the topography of thesurface 105 and various distances with respect to the surface 105.

As in this illustrated embodiment, the imaging device 120 can include anoptical waveform emitter 123, such as by being mounted on or otherwiseattached on the imaging device 120. The optical waveform emitter 123 isconfigured to emit electromagnetic radiation 124 (near-infrared (NIR)photons) that can penetrate the surface 105 of the tissue 103 and reachthe critical structure 101. The imaging device 120 and the opticalwaveform emitter 123 can be positionable by the robotic arm 114. Theoptical waveform emitter 123 is mounted on or otherwise on the imagingdevice 122 but in other embodiments can be positioned on a separatesurgical device from the imaging device 120. A corresponding waveformsensor 122 (e.g., an image sensor, spectrometer, or vibrational sensor)of the imaging device 120 is configured to detect the effect of theelectromagnetic radiation received by the waveform sensor 122. Thewavelengths of the electromagnetic radiation 124 emitted by the opticalwaveform emitter 123 are configured to enable the identification of thetype of anatomical and/or physical structure, such as the criticalstructure 101. The identification of the critical structure 101 can beaccomplished through spectral analysis, photo-acoustics, and/orultrasound, for example. In one aspect, the wavelengths of theelectromagnetic radiation 124 can be variable. The waveform sensor 122and optical waveform emitter 123 can be inclusive of a multispectralimaging system and/or a selective spectral imaging system, for example.In other instances, the waveform sensor 122 and optical waveform emitter123 can be inclusive of a photoacoustic imaging system, for example.

The distance sensor system 104 of the surgical visualization system 100is configured to determine one or more distances at the surgical site.The distance sensor system 104 can be a time-of-flight distance sensorsystem that includes an emitter, such as the emitter 106 as in thisillustrated embodiment, and that includes a receiver 108. In otherinstances, the time-of-flight emitter can be separate from thestructured light emitter. The emitter 106 can include a very tiny lasersource, and the receiver 108 can include a matching sensor. The distancesensor system 104 is configured to detect the “time of flight,” or howlong the laser light emitted by the emitter 106 has taken to bounce backto the sensor portion of the receiver 108. Use of a very narrow lightsource in the emitter 106 enables the distance sensor system 104 todetermining the distance to the surface 105 of the tissue 103 directlyin front of the distance sensor system 104.

The receiver 108 of the distance sensor system 104 is positioned on thesurgical device 102 in this illustrated embodiment, but in otherembodiments the receiver 108 can be mounted on a separate surgicaldevice instead of the surgical device 102. For example, the receiver 108can be mounted on a cannula or trocar through which the surgical device102 extends to reach the surgical site. In still other embodiments, thereceiver 108 for the distance sensor system 104 can be mounted on aseparate robotically-controlled arm of the robotic system 110 (e.g., onthe second robotic arm 114) than the first robotic arm 112 to which thesurgical device 102 is coupled, can be mounted on a movable arm that isoperated by another robot, or be mounted to an operating room (OR) tableor fixture. In some embodiments, the imaging device 120 includes thereceiver 108 to allow for determining the distance from the emitter 106to the surface 105 of the tissue 103 using a line between the emitter106 on the surgical device 102 and the imaging device 120. For example,the distance d_(e) can be triangulated based on known positions of theemitter 106 (on the surgical device 102) and the receiver 108 (on theimaging device 120) of the distance sensor system 104. Thethree-dimensional position of the receiver 108 can be known and/orregistered to the robot coordinate plane intraoperatively.

As in this illustrated embodiment, the position of the emitter 106 ofthe distance sensor system 104 can be controlled by the first roboticarm 112, and the position of the receiver 108 of the distance sensorsystem 104 can be controlled by the second robotic arm 114. In otherembodiments, the surgical visualization system 100 can be utilized apartfrom a robotic system. In such instances, the distance sensor system 104can be independent of the robotic system.

In FIG. 1 , d_(e) is emitter-to-tissue distance from the emitter 106 tothe surface 105 of the tissue 103, and d_(t) is device-to-tissuedistance from a distal end of the surgical device 102 to the surface 105of the tissue 103. The distance sensor system 104 is configured todetermine the emitter-to-tissue distance d_(e). The device-to-tissuedistance d_(t) is obtainable from the known position of the emitter 106on the surgical device 102, e.g., on a shaft thereof proximal to thesurgical device's distal end, relative to the distal end of the surgicaldevice 102. In other words, when the distance between the emitter 106and the distal end of the surgical device 102 is known, thedevice-to-tissue distance d_(t) can be determined from theemitter-to-tissue distance d_(e). In some embodiments, the shaft of thesurgical device 102 can include one or more articulation joints and canbe articulatable with respect to the emitter 106 and jaws at the distalend of the surgical device 102. The articulation configuration caninclude a multi-joint vertebrae-like structure, for example. In someembodiments, a three-dimensional camera can be utilized to triangulateone or more distances to the surface 105.

In FIG. 1 , d_(w) is camera-to-critical structure distance from theoptical waveform emitter 123 located on the imaging device 120 to thesurface of the critical structure 101, and d_(A) is a depth of thecritical structure 101 below the surface 105 of the tissue 103 (e.g.,the distance between the portion of the surface 105 closest to thesurgical device 102 and the critical structure 101). The time-of-flightof the optical waveforms emitted from the optical waveform emitter 123located on the imaging device 120 are configured to determine thecamera-to-critical structure distance d_(w).

As shown in FIG. 2 , the depth d_(A) of the critical structure 101relative to the surface 105 of the tissue 103 can be determined bytriangulating from the distance d_(w) and known positions of the emitter106 on the surgical device 102 and the optical waveform emitter 123 onthe imaging device 120 (and, thus, the known distance d_(x)therebetween) to determine the distance d_(y), which is the sum of thedistances d_(e) and d_(A). Additionally or alternatively, time-of-flightfrom the optical waveform emitter 123 can be configured to determine thedistance from the optical waveform emitter 123 to the surface 105 of thetissue 103. For example, a first waveform (or range of waveforms) can beutilized to determine the camera-to-critical structure distance d_(w)and a second waveform (or range of waveforms) can be utilized todetermine the distance to the surface 105 of the tissue 103. In suchinstances, the different waveforms can be utilized to determine thedepth of the critical structure 101 below the surface 105 of the tissue103.

Additionally or alternatively, the distance d_(A) can be determined froman ultrasound, a registered magnetic resonance imaging (MRI), orcomputerized tomography (CT) scan. In still other instances, thedistance d_(A) can be determined with spectral imaging because thedetection signal received by the imaging device 120 can vary based onthe type of material, e.g., type of the tissue 103. For example, fat candecrease the detection signal in a first way, or a first amount, andcollagen can decrease the detection signal in a different, second way,or a second amount.

In another embodiment of a surgical visualization system 160 illustratedin FIG. 3 , a surgical device 162, and not the imaging device 120,includes the optical waveform emitter 123 and the waveform sensor 122that is configured to detect the reflected waveforms. The opticalwaveform emitter 123 is configured to emit waveforms for determining thedistances d_(t) and d_(w) from a common device, such as the surgicaldevice 162, as described herein. In such instances, the distance d_(A)from the surface 105 of the tissue 103 to the surface of the criticalstructure 101 can be determined as follows:

d _(A) =d _(w) −d _(t)

The surgical visualization system 100 includes a control systemconfigured to control various aspects of the surgical visualizationsystem 100. FIG. 4 illustrates one embodiment of a control system 133that can be utilized as the control system of the surgical visualizationsystem 100 (or other surgical visualization system described herein).The control system 133 includes a control circuit 132 configured to bein signal communication with a memory 134. The memory 134 is configuredto store instructions executable by the control circuit 132, such asinstructions to determine and/or recognize critical structures (e.g.,the critical structure 101 of FIG. 1 ), instructions to determine and/orcompute one or more distances and/or three-dimensional digitalrepresentations, and instructions to communicate information to amedical practitioner. As in this illustrated embodiment, the memory 134can store surface mapping logic 136, imaging logic 138, tissueidentification logic 140, and distance determining logic 141, althoughthe memory 134 can store any combinations of the logics 136, 138, 140,141 and/or can combine various logics together. The control system 133also includes an imaging system 142 including a camera 144 (e.g., theimaging system including the imaging device 120 of FIG. 1 ), a display146 (e.g., a monitor, a computer tablet screen, etc.), and controls 148of the camera 144 and the display 146. The camera 144 includes an imagesensor 135 (e.g., the waveform sensor 122) configured to receive signalsfrom various light sources emitting light at various visible andinvisible spectra (e.g., visible light, spectral imagers,three-dimensional lens, etc.). The display 146 is configured to depictreal, virtual, and/or virtually-augmented images and/or information to amedical practitioner.

In an exemplary embodiment, the image sensor 135 is a solid-stateelectronic device containing up to millions of discrete photodetectorsites called pixels. The image sensor 135 technology falls into one oftwo categories: Charge-Coupled Device (CCD) and Complementary MetalOxide Semiconductor (CMOS) imagers and more recently, short-waveinfrared (SWIR) is an emerging technology in imaging. Another type ofthe image sensor 135 employs a hybrid CCD/CMOS architecture (sold underthe name “sCMOS”) and consists of CMOS readout integrated circuits(ROICs) that are bump bonded to a CCD imaging substrate. CCD and CMOSimage sensors 135 are sensitive to wavelengths in a range of about 350nm to about 1050 nm, such as in a range of about 400 nm to about 1000nm. A person skilled in the art will appreciate that a value may not beprecisely at a value but nevertheless considered to be about that valuefor any of a variety of reasons, such as sensitivity of measurementequipment and manufacturing tolerances. CMOS sensors are, in general,more sensitive to IR wavelengths than CCD sensors. Solid state imagesensors 135 are based on the photoelectric effect and, as a result,cannot distinguish between colors. Accordingly, there are two types ofcolor CCD cameras: single chip and three-chip. Single chip color CCDcameras offer a common, low-cost imaging solution and use a mosaic(e.g., Bayer) optical filter to separate incoming light into a series ofcolors and employ an interpolation algorithm to resolve full colorimages. Each color is, then, directed to a different set of pixels.Three-chip color CCD cameras provide higher resolution by employing aprism to direct each section of the incident spectrum to a differentchip. More accurate color reproduction is possible, as each point inspace of the object has separate RGB intensity values, rather than usingan algorithm to determine the color. Three-chip cameras offer extremelyhigh resolutions.

The control system 133 also includes an emitter (e.g., the emitter 106)including a spectral light source 150 and a structured light source 152each operably coupled to the control circuit 133. A single source can bepulsed to emit wavelengths of light in the spectral light source 150range and wavelengths of light in the structured light source 152 range.Alternatively, a single light source can be pulsed to provide light inthe invisible spectrum (e.g., infrared spectral light) and wavelengthsof light on the visible spectrum. The spectral light source 150 can be,for example, a hyperspectral light source, a multispectral light source,and/or a selective spectral light source. The tissue identificationlogic 140 is configured to identify critical structure(s) (e.g., thecritical structure 101 of FIG. 1 ) via data from the spectral lightsource 150 received by the image sensor 135 of the camera 144. Thesurface mapping logic 136 is configured to determine the surfacecontours of the visible tissue (e.g., the tissue 103) based on reflectedstructured light. With time-of-flight measurements, the distancedetermining logic 141 is configured to determine one or more distance(s)to the visible tissue and/or the critical structure. Output from each ofthe surface mapping logic 136, the tissue identification logic 140, andthe distance determining logic 141 is configured to be provided to theimaging logic 138, and combined, blended, and/or overlaid by the imaginglogic 138to be conveyed to a medical practitioner via the display 146 ofthe imaging system 142.

The control circuit 132 can have a variety of configurations. FIG. 5illustrates one embodiment of a control circuit 170 that can be used asthe control circuit 132 configured to control aspects of the surgicalvisualization system 100. The control circuit 170 is configured toimplement various processes described herein. The control circuit 170includes a microcontroller that includes a processor 172 (e.g., amicroprocessor or microcontroller) operably coupled to a memory 174. Thememory 174 is configured to store machine-executable instructions that,when executed by the processor 172, cause the processor 172 to executemachine instructions to implement various processes described herein.The processor 172 can be any one of a number of single-core or multicoreprocessors known in the art. The memory 174 can include volatile andnon-volatile storage media. The processor 172 includes an instructionprocessing unit 176 and an arithmetic unit 178. The instructionprocessing unit 176 is configured to receive instructions from thememory 174.

The surface mapping logic 136, the imaging logic 138, the tissueidentification logic 140, and the distance determining logic 141 canhave a variety of configurations. FIG. 6 illustrates one embodiment of acombinational logic circuit 180 configured to control aspects of thesurgical visualization system 100 using logic such as one or more of thesurface mapping logic 136, the imaging logic 138, the tissueidentification logic 140, and the distance determining logic 141. Thecombinational logic circuit 180 includes a finite state machine thatincludes a combinational logic 182 configured to receive data associatedwith a surgical device (e.g. the surgical device 102 and/or the imagingdevice 120) at an input 184, process the data by the combinational logic182, and provide an output 184 to a control circuit (e.g., the controlcircuit 132).

FIG. 7 illustrates one embodiment of a sequential logic circuit 190configured to control aspects of the surgical visualization system 100using logic such as one or more of the surface mapping logic 136, theimaging logic 138, the tissue identification logic 140, and the distancedetermining logic 141. The sequential logic circuit 190 includes afinite state machine that includes a combinational logic 192, a memory194, and a clock 196. The memory 194 is configured to store a currentstate of the finite state machine. The sequential logic circuit 190 canbe synchronous or asynchronous. The combinational logic 192 isconfigured to receive data associated with a surgical device (e.g. thesurgical device 102 and/or the imaging device 120) at an input 426,process the data by the combinational logic 192, and provide an output499 to a control circuit (e.g., the control circuit 132). In someembodiments, the sequential logic circuit 190 can include a combinationof a processor (e.g., processor 172 of FIG. 5 ) and a finite statemachine to implement various processes herein. In some embodiments, thefinite state machine can include a combination of a combinational logiccircuit (e.g., the combinational logic circuit 192 of FIG. 7 ) and thesequential logic circuit 190.

FIG. 8 illustrates another embodiment of a surgical visualization system200. The surgical visualization system 200 is generally configured andused similar to the surgical visualization system 100 of FIG. 1 , e.g.,includes a surgical device 202 and an imaging device 220. The imagingdevice 220 includes a spectral light emitter 223 configured to emitspectral light in a plurality of wavelengths to obtain a spectral imageof hidden structures, for example. The imaging device 220 can alsoinclude a three-dimensional camera and associated electronic processingcircuits. The surgical visualization system 200 is shown being utilizedintraoperatively to identify and facilitate avoidance of certaincritical structures, such as a ureter 201 a and vessels 201 b, in anorgan 203 (a uterus in this embodiment) that are not visible on asurface 205 of the organ 203.

The surgical visualization system 200 is configured to determine anemitter-to-tissue distance d_(e) from an emitter 206 on the surgicaldevice 202 to the surface 205 of the uterus 203 via structured light.The surgical visualization system 200 is configured to extrapolate adevice-to-tissue distance d_(t) from the surgical device 202 to thesurface 205 of the uterus 203 based on the emitter-to-tissue distanced_(e). The surgical visualization system 200 is also configured todetermine a tissue-to-ureter distance d_(A) from the ureter 201 a to thesurface 205 and a camera-to ureter distance d_(w) from the imagingdevice 220 to the ureter 201 a. As described herein, e.g., with respectto the surgical visualization system 100 of FIG. 1 , the surgicalvisualization system 200 is configured to determine the distance d_(w)with spectral imaging and time-of-flight sensors, for example. Invarious embodiments, the surgical visualization system 200 can determine(e.g. triangulate) the tissue-to-ureter distance d_(A) (or depth) basedon other distances and/or the surface mapping logic described herein.

As mentioned above, a surgical visualization system includes a controlsystem configured to control various aspects of the surgicalvisualization system. The control system can have a variety ofconfigurations. FIG. 9 illustrates one embodiment of a control system600 for a surgical visualization system, such as the surgicalvisualization system 100 of FIG. 1 , the surgical visualization system200 of FIG. 8 , or other surgical visualization system described herein.The control system 600 is a conversion system that integrates spectralsignature tissue identification and structured light tissue positioningto identify a critical structure, especially when those structure(s) areobscured by tissue, e.g., by fat, connective tissue, blood tissue,and/or organ(s), and/or by blood, and/or to detect tissue variability,such as differentiating tumors and/or non-healthy tissue from healthytissue within an organ.

The control system 600 is configured for implementing a hyperspectralimaging and visualization system in which a molecular response isutilized to detect and identify anatomy in a surgical field of view. Thecontrol system 600 includes a conversion logic circuit 648 configured toconvert tissue data to usable information for surgeons and/or othermedical practitioners. For example, variable reflectance based onwavelengths with respect to obscuring material can be utilized toidentify the critical structure in the anatomy. Moreover, the controlsystem 600 is configured to combine the identified spectral signatureand the structural light data in an image. For example, the controlsystem 600 can be employed to create of three-dimensional data set forsurgical use in a system with augmentation image overlays. Techniquescan be employed both intraoperatively and preoperatively usingadditional visual information. In various embodiments, the controlsystem 600 is configured to provide warnings to a medical practitionerwhen in the proximity of one or more critical structures. Variousalgorithms can be employed to guide robotic automation andsemi-automated approaches based on the surgical procedure and proximityto the critical structure(s).

A projected array of lights is employed by the control system 600 todetermine tissue shape and motion intraoperatively. Alternatively, flashLidar may be utilized for surface mapping of the tissue.

The control system 600 is configured to detect the critical structure,which as mentioned above can include one or more critical structures,and provide an image overlay of the critical structure and measure thedistance to the surface of the visible tissue and the distance to theembedded/buried critical structure(s). The control system 600 canmeasure the distance to the surface of the visible tissue or detect thecritical structure and provide an image overlay of the criticalstructure.

The control system 600 includes a spectral control circuit 602. Thespectral control circuit 602 can be a field programmable gate array(FPGA) or another suitable circuit configuration, such as theconfigurations described with respect to FIG. 6 , FIG. 7 , and FIG. 8 .The spectral control circuit 602 includes a processor 604 configured toreceive video input signals from a video input processor 606. Theprocessor 604 can be configured for hyperspectral processing and canutilize C/C++ code, for example. The video input processor 606 isconfigured to receive video-in of control (metadata) data such asshutter time, wave length, and sensor analytics, for example. Theprocessor 604 is configured to process the video input signal from thevideo input processor 606 and provide a video output signal to a videooutput processor 608, which includes a hyperspectral video-out ofinterface control (metadata) data, for example. The video outputprocessor 608 is configured to provides the video output signal to animage overlay controller 610.

The video input processor 606 is operatively coupled to a camera 612 atthe patient side via a patient isolation circuit 614. The camera 612includes a solid state image sensor 634. The patient isolation circuit614 can include a plurality of transformers so that the patient isisolated from other circuits in the system. The camera 612 is configuredto receive intraoperative images through optics 632 and the image sensor634. The image sensor 634 can include a CMOS image sensor, for example,or can include another image sensor technology, such as those discussedherein in connection with FIG. 4 . The camera 612 is configured tooutput 613 images in 14 bit/pixel signals. A person skilled in the artwill appreciate that higher or lower pixel resolutions can be employed.The isolated camera output signal 613 is provided to a color RGB fusioncircuit 616, which in this illustrated embodiment employs a hardwareregister 618 and a Nios2 co-processor 620 configured to process thecamera output signal 613. A color RGB fusion output signal is providedto the video input processor 606 and a laser pulsing control circuit622.

The laser pulsing control circuit 622 is configured to control a laserlight engine 624. The laser light engine 624 is configured to outputlight in a plurality of wavelengths (λ1, λ2, λ3 . . . λn) including nearinfrared (NIR). The laser light engine 624 can operate in a plurality ofmodes. For example, the laser light engine 624 can operate in two modes.In a first mode, e.g., a normal operating mode, the laser light engine624 is configured to output an illuminating signal. In a second mode,e.g., an identification mode, the laser light engine 624 is configuredto output RGBG and NIR light. In various embodiments, the laser lightengine 624 can operate in a polarizing mode.

Light output 626 from the laser light engine 624 is configured toilluminate targeted anatomy in an intraoperative surgical site 627. Thelaser pulsing control circuit 622 is also configured to control a laserpulse controller 628 for a laser pattern projector 630 configured toproject a laser light pattern 631, such as a grid or pattern of linesand/or dots, at a predetermined wavelength (λ2) on an operative tissueor organ at the surgical site 627. The camera 612 is configured toreceive the patterned light as well as the reflected light outputthrough the camera optics 632. The image sensor 634 is configured toconvert the received light into a digital signal.

The color RGB fusion circuit 616 is also configured to output signals tothe image overlay controller 610 and a video input module 636 forreading the laser light pattern 631 projected onto the targeted anatomyat the surgical site 627 by the laser pattern projector 630. Aprocessing module 638 is configured to process the laser light pattern631 and output a first video output signal 640 representative of thedistance to the visible tissue at the surgical site 627. The data isprovided to the image overlay controller 610. The processing module 638is also configured to output a second video signal 642 representative ofa three-dimensional rendered shape of the tissue or organ of thetargeted anatomy at the surgical site.

The first and second video output signals 640, 642 include datarepresentative of the position of the critical structure on athree-dimensional surface model, which is provided to an integrationmodule 643. In combination with data from the video out processor 608 ofthe spectral control circuit 602, the integration module 643 isconfigured to determine the distance (e.g., distance d_(A) of FIG. 1 )to a buried critical structure (e.g., via triangularization algorithms644), and the distance to the buried critical structure can be providedto the image overlay controller 610 via a video out processor 646. Theforegoing conversion logic can encompass the conversion logic circuit648 intermediate video monitors 652 and the camera 624/laser patternprojector 630 positioned at the surgical site 627.

Preoperative data 650, such as from a CT or MRI scan, can be employed toregister or align certain three-dimensional deformable tissue in variousinstances. Such preoperative data 650 can be provided to the integrationmodule 643 and ultimately to the image overlay controller 610 so thatsuch information can be overlaid with the views from the camera 612 andprovided to the video monitors 652. Embodiments of registration ofpreoperative data are further described in U.S. Pat. Pub. No.2020/0015907 entitled “Integration Of Imaging Data” filed Sep. 11, 2018,which is hereby incorporated by reference herein in its entirety.

The video monitors 652 are configured to output the integrated/augmentedviews from the image overlay controller 610. A medical practitioner canselect and/or toggle between different views on one or more displays. Ona first display 652 a, which is a monitor in this illustratedembodiment, the medical practitioner can toggle between (A) a view inwhich a three-dimensional rendering of the visible tissue is depictedand (B) an augmented view in which one or more hidden criticalstructures are depicted over the three-dimensional rendering of thevisible tissue. On a second display 652 b, which is a monitor in thisillustrated embodiment, the medical practitioner can toggle on distancemeasurements to one or more hidden critical structures and/or thesurface of visible tissue, for example.

The various surgical visualization systems described herein can beutilized to visualize various different types of tissues and/oranatomical structures, including tissues and/or anatomical structuresthat may be obscured from being visualized by EMR in the visible portionof the spectrum. The surgical visualization system can utilize aspectral imaging system, as mentioned above, which can be configured tovisualize different types of tissues based upon their varyingcombinations of constituent materials. In particular, a spectral imagingsystem can be configured to detect the presence of various constituentmaterials within a tissue being visualized based on the absorptioncoefficient of the tissue across various EMR wavelengths. The spectralimaging system can be configured to characterize the tissue type of thetissue being visualized based upon the particular combination ofconstituent materials.

FIG. 10 shows a graph 300 depicting how the absorption coefficient ofvarious biological materials varies across the EMR wavelength spectrum.In the graph 300, the vertical axis 302 represents absorptioncoefficient of the biological material in cm⁻¹, and the horizontal axis304 represents EMR wavelength in p.m. A first line 306 in the graph 300represents the absorption coefficient of water at various EMRwavelengths, a second line 308 represents the absorption coefficient ofprotein at various EMR wavelengths, a third line 310 represents theabsorption coefficient of melanin at various EMR wavelengths, a fourthline 312 represents the absorption coefficient of deoxygenatedhemoglobin at various EMR wavelengths, a fifth line 314 represents theabsorption coefficient of oxygenated hemoglobin at various EMRwavelengths, and a sixth line 316 represents the absorption coefficientof collagen at various EMR wavelengths. Different tissue types havedifferent combinations of constituent materials and, therefore, thetissue type(s) being visualized by a surgical visualization system canbe identified and differentiated between according to the particularcombination of detected constituent materials. Accordingly, a spectralimaging system of a surgical visualization system can be configured toemit EMR at a number of different wavelengths, determine the constituentmaterials of the tissue based on the detected absorption EMR absorptionresponse at the different wavelengths, and then characterize the tissuetype based on the particular detected combination of constituentmaterials.

FIG. 11 shows an embodiment of the utilization of spectral imagingtechniques to visualize different tissue types and/or anatomicalstructures. In FIG. 11 , a spectral emitter 320 (e.g., the spectrallight source 150 of FIG. 4 ) is being utilized by an imaging system tovisualize a surgical site 322. The EMR emitted by the spectral emitter320 and reflected from the tissues and/or structures at the surgicalsite 322 is received by an image sensor (e.g., the image sensor 135 ofFIG. 4 ) to visualize the tissues and/or structures, which can be eithervisible (e.g., be located at a surface of the surgical site 322) orobscured (e.g., underlay other tissue and/or structures at the surgicalsite 322). In this embodiment, an imaging system (e.g., the imagingsystem 142 of FIG. 4 ) visualizes a tumor 324, an artery 326, andvarious abnormalities 328 (e.g., tissues not confirming to known orexpected spectral signatures) based upon the spectral signaturescharacterized by the differing absorptive characteristics (e.g.,absorption coefficient) of the constituent materials for each of thedifferent tissue/structure types. The visualized tissues and structurescan be displayed on a display screen associated with or coupled to theimaging system (e.g., the display 146 of the imaging system 142 of FIG.4 ), on a primary display (e.g., the primary display 819 of FIG. 19 ),on a non-sterile display (e.g., the non-sterile displays 807, 809 ofFIG. 19 ), on a display of a surgical hub (e.g., the display of thesurgical hub 806 of FIG. 19 ), on a device/instrument display, and/or onanother display.

The imaging system can be configured to tailor or update the displayedsurgical site visualization according to the identified tissue and/orstructure types. For example, as shown in FIG. 11 , the imaging systemcan display a margin 330 associated with the tumor 324 being visualizedon a display screen associated with or coupled to the imaging system, ona primary display, on a non-sterile display, on a display of a surgicalhub, on a device/instrument display, and/or on another display. Themargin 330 can indicate the area or amount of tissue that should beexcised to ensure complete removal of the tumor 324. The surgicalvisualization system's control system (e.g., the control system 133 ofFIG. 4 ) can be configured to control or update the dimensions of themargin 330 based on the tissues and/or structures identified by theimaging system. In this illustrated embodiment, the imaging system hasidentified multiple abnormalities 328 within the field of view (FOV).Accordingly, the control system can adjust the displayed margin 330 to afirst updated margin 332 having sufficient dimensions to encompass theabnormalities 328. Further, the imaging system has also identified theartery 326 partially overlapping with the initially displayed margin 330(as indicated by a highlighted region 334 of the artery 326).Accordingly, the control system can adjust the displayed margin to asecond updated margin 336 having sufficient dimensions to encompass therelevant portion of the artery 326.

Tissues and/or structures can also be imaged or characterized accordingto their reflective characteristics, in addition to or in lieu of theirabsorptive characteristics described above with respect to FIG. 10 andFIG. 11 , across the EMR wavelength spectrum. For example, FIG. 12 ,FIG. 13 , and FIG. 14 illustrate various graphs of reflectance ofdifferent types of tissues or structures across different EMRwavelengths. FIG. 12 is a graphical representation 340 of anillustrative ureter signature versus obscurants. FIG. 13 is a graphicalrepresentation 342 of an illustrative artery signature versusobscurants. FIG. 14 is a graphical representation 344 of an illustrativenerve signature versus obscurants. The plots in FIG. 12 , FIG. 13 , andFIG. 14 represent reflectance as a function of wavelength (nm) for theparticular structures (ureter, artery, and nerve) relative to thecorresponding reflectances of fat, lung tissue, and blood at thecorresponding wavelengths. These graphs are simply for illustrativepurposes and it should be understood that other tissues and/orstructures could have corresponding detectable reflectance signaturesthat would allow the tissues and/or structures to be identified andvisualized.

Select wavelengths for spectral imaging can be identified and utilizedbased on the anticipated critical structures and/or obscurants at asurgical site (e.g., “selective spectral” imaging). By utilizingselective spectral imaging, the amount of time required to obtain thespectral image can be minimized such that the information can beobtained in real-time and utilized intraoperatively. The wavelengths canbe selected by a medical practitioner or by a control circuit based oninput by a user, e.g., a medical practitioner. In certain instances, thewavelengths can be selected based on machine learning and/or big dataaccessible to the control circuit via, e.g., a cloud or surgical hub.

FIG. 15 illustrates one embodiment of spectral imaging to tissue beingutilized intraoperatively to measure a distance between a waveformemitter and a critical structure that is obscured by tissue. FIG. 15shows an embodiment of a time-of-flight sensor system 404 utilizingwaveforms 424, 425. The time-of-flight sensor system 404 can beincorporated into a surgical visualization system, e.g., as the sensorsystem 104 of the surgical visualization system 100 of FIG. 1 . Thetime-of-flight sensor system 404 includes a waveform emitter 406 and awaveform receiver 408 on the same surgical device 402 (e.g., the emitter106 and the receiver 108 on the same surgical device 102 of FIG. 1 ).The emitted wave 400 extends to a critical structure 401 (e.g., thecritical structure 101 of FIG. 1 ) from the emitter 406, and thereceived wave 425 is reflected back to by the receiver 408 from thecritical structure 401. The surgical device 402 in this illustratedembodiment is positioned through a trocar 410 that extends into a cavity407 in a patient. Although the trocar 410 is used in this in thisillustrated embodiment, other trocars or other access devices can beused, or no access device may be used.

The waveforms 424, 425 are configured to penetrate obscuring tissue 403,such as by having wavelengths in the NIR or SWIR spectrum ofwavelengths. A spectral signal (e.g., hyperspectral, multispectral, orselective spectral) or a photoacoustic signal is emitted from theemitter 406, as shown by a first arrow 407 pointing distally, and canpenetrate the tissue 403 in which the critical structure 401 isconcealed. The emitted waveform 424 is reflected by the criticalstructure 401, as shown by a second arrow 409 pointing proximally. Thereceived waveform 425 can be delayed due to a distance d between adistal end of the surgical device 402 and the critical structure 401.The waveforms 424, 425 can be selected to target the critical structure401 within the tissue 403 based on the spectral signature of thecritical structure 401, as described herein. The emitter 406 isconfigured to provide a binary signal on and off, as shown in FIG. 16 ,for example, which can be measured by the receiver 408.

Based on the delay between the emitted wave 424 and the received wave425, the time-of-flight sensor system 404 is configured to determine thedistance d. A time-of-flight timing diagram 430 for the emitter 406 andthe receiver 408 of FIG. 15 is shown in FIG. 16 . The delay is afunction of the distance d and the distance d is given by:

$d = {\frac{ct}{2} \cdot \frac{q_{2}}{q_{1} + q_{2}}}$$\left\lbrack \left\lbrack {d = {\begin{matrix}{Ct} \\2\end{matrix} \cdot \frac{\overset{\_}{q_{2}}}{q_{1} + q_{2}}}} \right\rbrack \right\rbrack$

where c=the speed of light; t=length of pulse; q1=accumulated chargewhile light is emitted; and q2=accumulated charge while light is notbeing emitted.

The time-of-flight of the waveforms 424, 425 corresponds to the distanced in FIG. 15 . In various instances, additional emitters/receiversand/or pulsing signals from the emitter 406 can be configured to emit anon-penetrating signal. The non-penetrating signal can be configured todetermine the distance from the emitter 406 to the surface 405 of theobscuring tissue 403. In various instances, a depth of the criticalstructure 401 can be determined by:

d _(A) =d _(w) −d _(t)

where d_(A)=the depth of the critical structure 401; d_(w)=the distancefrom the emitter 406 to the critical structure 401 (d in FIG. 15 ); andd_(t),=the distance from the emitter 406 (on the distal end of thesurgical device 402) to the surface 405 of the obscuring tissue 403.

FIG. 17 illustrates another embodiment of a time-of-flight sensor system504 utilizing waves 524 a, 524 b, 524 c, 525 a, 525 b, 525 c is shown.The time-of-flight sensor system 504 can be incorporated into a surgicalvisualization system, e.g., as the sensor system 104 of the surgicalvisualization system 100 of FIG. 1 . The time-of-flight sensor system504 includes a waveform emitter 506 and a waveform receiver 508 (e.g.,the emitter 106 and the receiver 108 of FIG. 1 ). The waveform emitter506 is positioned on a first surgical device 502 a (e.g., the surgicaldevice 102 of FIG. 1 ), and the waveform receiver 508 is positioned on asecond surgical device 502 b. The surgical devices 502 a, 502 b arepositioned through first and second trocars 510 a, 510 b, respectively,which extend into a cavity 507 in a patient. Although the trocars 510 a,510 b are used in this in this illustrated embodiment, other trocars orother access devices can be used, or no access device may be used. Theemitted waves 524 a, 524 b, 524 c extend toward a surgical site from theemitter 506, and the received waves 525 a, 525 b, 525 c are reflectedback to the receiver 508 from various structures and/or surfaces at thesurgical site.

The different emitted waves 524 a, 524 b, 524 c are configured to targetdifferent types of material at the surgical site. For example, the wave524 a targets obscuring tissue 503, the wave 524 b targets a firstcritical structure 501 a (e.g., the critical structure 101 of FIG. 1 ),which is a vessel in this illustrated embodiment, and the wave 524 ctargets a second critical structure 501 b (e.g., the critical structure101 of FIG. 1 ), which is a cancerous tumor in this illustratedembodiment. The wavelengths of the waves 524 a, 524 b, 524 c can be inthe visible light, NIR, or SWIR spectrum of wavelengths. For example,visible light can be reflected off a surface 505 of the tissue 503, andNIR and/or SWIR waveforms can penetrate the surface 505 of the tissue503. In various aspects, as described herein, a spectral signal (e.g.,hyperspectral, multispectral, or selective spectral) or a photoacousticsignal can be emitted from the emitter 506. The waves 524 b, 524 c canbe selected to target the critical structures 501 a, 501 b within thetissue 503 based on the spectral signature of the critical structure 501a, 501 b, as described herein. Photoacoustic imaging is furtherdescribed in various U.S. patent applications, which are incorporated byreference herein in the present disclosure.

The emitted waves 524 a, 524 b, 524 c are reflected off the targetedmaterial, namely the surface 505, the first critical structure 501 a,and the second structure 501 b, respectively. The received waveforms 525a, 525 b, 525 c can be delayed due to distances d_(1a), d_(2a), d_(3a),d_(1b), d_(2b), d_(2c)

In the time-of-flight sensor system 504, in which the emitter 506 andthe receiver 508 are independently positionable (e.g., on separatesurgical devices 502 a, 502 b and/or controlled by separate roboticarms), the various distances d_(1a), d_(2a), d_(3a), d_(1b), d_(2b),d_(2c) can be calculated from the known position of the emitter 506 andthe receiver 508. For example, the positions can be known when thesurgical devices 502 a, 502 b are robotically-controlled. Knowledge ofthe positions of the emitter 506 and the receiver 508, as well as thetime of the photon stream to target a certain tissue and the informationreceived by the receiver 508 of that particular response can allow adetermination of the distances d_(1a), d_(2a), d_(3a), d_(1b), d_(2b),d_(2c). In one aspect, the distance to the obscured critical structures501 a, 501 b can be triangulated using penetrating wavelengths. Becausethe speed of light is constant for any wavelength of visible orinvisible light, the time-of-flight sensor system 504 can determine thevarious distances.

In a view provided to the medical practitioner, such as on a display,the receiver 508 can be rotated such that a center of mass of the targetstructure in the resulting images remains constant, e.g., in a planeperpendicular to an axis of a select target structure 503, 501 a, or 501b. Such an orientation can quickly communicate one or more relevantdistances and/or perspectives with respect to the target structure. Forexample, as shown in FIG. 17 , the surgical site is displayed from aviewpoint in which the critical structure 501 a is perpendicular to theviewing plane (e.g., the vessel is oriented in/out of the page). Such anorientation can be default setting; however, the view can be rotated orotherwise adjusted by a medical practitioner. In certain instances, themedical practitioner can toggle between different surfaces and/or targetstructures that define the viewpoint of the surgical site provided bythe imaging system.

As in this illustrated embodiment, the receiver 508 can be mounted onthe trocar 510 b (or other access device) through which the surgicaldevice 502 b is positioned. In other embodiments, the receiver 508 canbe mounted on a separate robotic arm for which the three-dimensionalposition is known. In various instances, the receiver 508 can be mountedon a movable arm that is separate from a robotic surgical system thatcontrols the surgical device 502 a or can be mounted to an operatingroom (OR) table or fixture that is intraoperatively registerable to therobot coordinate plane. In such instances, the position of the emitter506 and the receiver 508 can be registerable to the same coordinateplane such that the distances can be triangulated from outputs from thetime-of-flight sensor system 504.

Combining time-of-flight sensor systems and near-infrared spectroscopy(NIRS), termed TOF-NIRS, which is capable of measuring the time-resolvedprofiles of NIR light with nanosecond resolution can be found in“Time-Of-Flight Near-Infrared Spectroscopy For NondestructiveMeasurement Of Internal Quality In Grapefruit,” Journal of the AmericanSociety for Horticultural Science, May 2013 vol. 138 no. 3 225-228,which is hereby incorporated by reference in its entirety.

Embodiments of visualization systems and aspects and uses thereof aredescribed further in U.S. Pat. Pub. No. 2020/0015923 entitled “SurgicalVisualization Platform” filed Sep. 11, 2018, U.S. Pat. Pub. No.2020/0015900 entitled “Controlling An Emitter Assembly Pulse Sequence”filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015668 entitled “SingularEMR Source Emitter Assembly” filed Sep. 11, 2018, U.S. Pat. Pub. No.2020/0015925 entitled “Combination Emitter And Camera Assembly” filedSep. 11, 2018, U.S. Pat. Pub. No. 2020/00015899 entitled “SurgicalVisualization With Proximity Tracking Features” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2020/00015903 entitled “Surgical Visualization OfMultiple Targets” filed Sep. 11, 2018, U.S. Pat. No. 10,792,034 entitled“Visualization Of Surgical Devices” filed Sep. 11, 2018, U.S. Pat. Pub.No. 2020/0015897 entitled “Operative Communication Of Light” filed Sep.11, 2018, U.S. Pat. Pub. No. 2020/0015924 entitled “Robotic LightProjection Tools” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015898entitled “Surgical Visualization Feedback System” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2020/0015906 entitled “Surgical Visualization AndMonitoring” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015907entitled “Integration Of Imaging Data” filed Sep. 11, 2018, U.S. Pat.No. 10,925,598 entitled “Robotically-Assisted Surgical Suturing Systems”filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015901 entitled “SafetyLogic For Surgical Suturing Systems” filed Sep. 11, 2018, U.S. Pat. Pub.No. 2020/0015914 entitled “Robotic Systems With Separate PhotoacousticReceivers” filed Sep. 11, 2018, U.S. Pat. Pub. No. 2020/0015902 entitled“Force Sensor Through Structured Light Deflection” filed Sep. 11, 2018,U.S. Pat. Pub. No. 2019/0201136 entitled “Method Of Hub Communication”filed Dec. 4, 2018, U.S. patent application Ser. No. 16/729,772 entitled“Analyzing Surgical Trends By A Surgical System” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,747 entitled “Dynamic SurgicalVisualization Systems” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,744 entitled “Visualization Systems Using Structured Light”filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,778 entitled “System AndMethod For Determining, Adjusting, And Managing Resection Margin About ASubject Tissue” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,729 entitled “Surgical Systems For Proposing And CorroboratingOrgan Portion Removals” filed Dec. 30, 2019, U.S. patent applicationSer. No. 16/729,778 entitled “Surgical System For Overlaying SurgicalInstrument Data Onto A Virtual Three Dimensional Construct Of An Organ”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,751entitled “Surgical Systems For Generating Three Dimensional ConstructsOf Anatomical Organs And Coupling Identified Anatomical StructuresThereto” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,740 entitled “Surgical Systems Correlating Visualization Data AndPowered Surgical Instrument Data” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,737 entitled “Adaptive Surgical SystemControl According To Surgical Smoke Cloud Characteristics” filed Dec.30, 2019, U.S. patent application Ser. No. 16/729,796 entitled “AdaptiveSurgical System Control According To Surgical Smoke ParticulateCharacteristics” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,803 entitled “Adaptive Visualization By A Surgical System” filedDec. 30, 2019, U.S. patent application Ser. No. 16/729,807 entitled“Method Of Using Imaging Devices In Surgery” filed Dec. 30, 2019, U.S.Prov. Pat. App. No. 63/249,652 entitled “Surgical Devices, Systems, andMethods Using Fiducial Identification and Tracking” filed on Sep. 29,2021, U.S. Prov. Pat. App. No. 63/249,658 entitled “Surgical Devices,Systems, and Methods for Control of One Visualization with Another”filed on Sep. 29, 2021, U.S. Prov. Pat. App. No. 63/249,870 entitled“Methods and Systems for Controlling Cooperative Surgical Instruments”filed on Sep. 29, 2021, U.S. Prov. Pat. App. No. 63/249,881 entitled“Methods and Systems for Controlling Cooperative Surgical Instrumentswith Variable Surgical Site Access Trajectories” filed on Sep. 29, 2021,U.S. Prov. Pat. App. No. 63/249,877 entitled “Methods and Systems forControlling Cooperative Surgical Instruments” filed on Sep. 29, 2021,and U.S. Prov. Pat. App. No. 63/249,980 entitled “Cooperative Access”filed on Sep. 29, 2021, which are hereby incorporated by reference intheir entireties.

Surgical Hubs

The various visualization or imaging systems described herein can beincorporated into a system that includes a surgical hub. In general, asurgical hub can be a component of a comprehensive digital medicalsystem capable of spanning multiple medical facilities and configured toprovide integrated and comprehensive improved medical care to a vastnumber of patients. The comprehensive digital medical system includes acloud-based medical analytics system that is configured to interconnectto multiple surgical hubs located across many different medicalfacilities. The surgical hubs are configured to interconnect with one ormore elements, such as one or more surgical instruments that are used toconduct medical procedures on patients and/or one or more visualizationsystems that are used during performance of medical procedures. Thesurgical hubs provide a wide array of functionality to improve theoutcomes of medical procedures. The data generated by the varioussurgical devices, visualization systems, and surgical hubs about thepatient and the medical procedure may be transmitted to the cloud-basedmedical analytics system. This data may then be aggregated with similardata gathered from many other surgical hubs, visualization systems, andsurgical instruments located at other medical facilities. Variouspatterns and correlations may be found through the cloud-based analyticssystem analyzing the collected data. Improvements in the techniques usedto generate the data may be generated as a result, and theseimprovements may then be disseminated to the various surgical hubs,visualization systems, and surgical instruments. Due to theinterconnectedness of all of the aforementioned components, improvementsin medical procedures and practices may be found that otherwise may notbe found if the many components were not so interconnected.

Examples of surgical hubs configured to receive, analyze, and outputdata, and methods of using such surgical hubs, are further described inU.S. Pat. Pub. No. 2019/0200844 entitled “Method Of Hub Communication,Processing, Storage And Display” filed Dec. 4, 2018, U.S. Pat. Pub. No.2019/0200981 entitled “Method Of Compressing Tissue Within A StaplingDevice And Simultaneously Displaying The Location Of The Tissue WithinThe Jaws” filed Dec. 4, 2018, U.S. Pat. Pub. No. 2019/0201046 entitled“Method For Controlling Smart Energy Devices” filed Dec. 4, 2018, U.S.Pat. Pub. No. 2019/0201114 entitled “Adaptive Control Program UpdatesFor Surgical Hubs” filed Mar. 29, 2018, U.S. Pat. Pub. No. 2019/0201140entitled “Surgical Hub Situational Awareness” filed Mar. 29, 2018, U.S.Pat. Pub. No. 2019/0206004 entitled “Interactive Surgical Systems WithCondition Handling Of Devices And Data Capabilities” filed Mar. 29,2018, U.S. Pat. Pub. No. 2019/0206555 entitled “Cloud-based MedicalAnalytics For Customization And Recommendations To A User” filed Mar.29, 2018, and U.S. Pat. Pub. No. 2019/0207857 entitled “Surgical NetworkDetermination Of Prioritization Of Communication, Interaction, OrProcessing Based On System Or Device Needs” filed Nov. 6, 2018, whichare hereby incorporated by reference in their entireties.

FIG. 18 illustrates one embodiment of a computer-implemented interactivesurgical system 700 that includes one or more surgical systems 702 and acloud-based system (e.g., a cloud 704 that can include a remote server713 coupled to a storage device 705). Each surgical system 702 includesat least one surgical hub 706 in communication with the cloud 704. Inone example, as illustrated in FIG. 18 , the surgical system 702includes a visualization system 708, a robotic system 710, and anintelligent (or “smart”) surgical instrument 712, which are configuredto communicate with one another and/or the hub 706. The intelligentsurgical instrument 712 can include imaging device(s). The surgicalsystem 702 can include an M number of hubs 706, an N number ofvisualization systems 708, an O number of robotic systems 710, and a Pnumber of intelligent surgical instruments 712, where M, N, O, and P areintegers greater than or equal to one that may or may not be equal toany one or more of each other. Various exemplary intelligent surgicalinstruments and robotic systems are described herein.

Data received by a surgical hub from a surgical visualization system canbe used in any of a variety of ways. In an exemplary embodiment, thesurgical hub can receive data from a surgical visualization system inuse with a patient in a surgical setting, e.g., in use in an operatingroom during performance of a surgical procedure. The surgical hub canuse the received data in any of one or more ways, as discussed herein.

The surgical hub can be configured to analyze received data in real timewith use of the surgical visualization system and adjust control one ormore of the surgical visualization system and/or one or more intelligentsurgical instruments in use with the patient based on the analysis ofthe received data. Such adjustment can include, for example, adjustingone or operational control parameters of intelligent surgicalinstrument(s), causing one or more sensors of one or more intelligentsurgical instruments to take a measurement to help gain an understandingof the patient's current physiological condition, and/or currentoperational status of an intelligent surgical instrument, and otheradjustments. Controlling and adjusting operation of intelligent surgicalinstruments is discussed further below. Examples of operational controlparameters of an intelligent surgical instrument include motor speed,cutting element speed, time, duration, level of energy application, andlight emission. Examples of surgical hubs and of controlling andadjusting intelligent surgical instrument operation are describedfurther in previously mentioned U.S. patent application Ser. No.16/729,772 entitled “Analyzing Surgical Trends By A Surgical System”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,747entitled “Dynamic Surgical Visualization Systems” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,744 entitled “VisualizationSystems Using Structured Light” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,778 entitled “System And Method ForDetermining, Adjusting, And Managing Resection Margin About A SubjectTissue” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,729entitled “Surgical Systems For Proposing And Corroborating Organ PortionRemovals” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,778 entitled “Surgical System For Overlaying Surgical InstrumentData Onto A Virtual Three Dimensional Construct Of An Organ” filed Dec.30, 2019, U.S. patent application Ser. No. 16/729,751 entitled “SurgicalSystems For Generating Three Dimensional Constructs Of Anatomical OrgansAnd Coupling Identified Anatomical Structures Thereto” filed Dec. 30,2019, U.S. patent application Ser. No. 16/729,740 entitled “SurgicalSystems Correlating Visualization Data And Powered Surgical InstrumentData” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,737entitled “Adaptive Surgical System Control According To Surgical SmokeCloud Characteristics” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,796 entitled “Adaptive Surgical System Control According ToSurgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,803 entitled “Adaptive VisualizationBy A Surgical System” filed Dec. 30, 2019, and U.S. patent applicationSer. No. 16/729,807 entitled “Method Of Using Imaging Devices InSurgery” filed Dec. 30, 2019, and in U.S. patent application Ser. No.17/068,857 entitled “Adaptive Responses From Smart Packaging Of DrugDelivery Absorbable Adjuncts” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,858 entitled “Drug Administration DevicesThat Communicate With Surgical Hubs” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,859 entitled “Controlling Operation Of DrugAdministration Devices Using Surgical Hubs” filed Oct. 13, 2020, U.S.patent application Ser. No. 17/068,863 entitled “Patient MonitoringUsing Drug Administration Devices” filed Oct. 13, 2020, U.S. patentapplication Ser. No. 17/068,865 entitled “Monitoring And CommunicatingInformation Using Drug Administration Devices” filed Oct. 13, 2020, andU.S. patent application Ser. No. 17/068,867 entitled “Aggregating AndAnalyzing Drug Administration Data” filed Oct. 13, 2020, which arehereby incorporated by reference in their entireties.

The surgical hub can be configured to cause visualization of thereceived data to be provided in the surgical setting on a display sothat a medical practitioner in the surgical setting can view the dataand thereby receive an understanding of the operation of the imagingdevice(s) in use in the surgical setting. Such information provided viavisualization can include text and/or images.

FIG. 19 illustrates one embodiment of a surgical system 802 including asurgical hub 806 (e.g., the surgical hub 706 of FIG. 18 or othersurgical hub described herein), a robotic surgical system 810 (e.g., therobotic surgical system 110 of FIG. 1 or other robotic surgical systemherein), and a visualization system 808 (e.g., the visualization system100 of FIG. 1 or other visualization system described herein). Thesurgical hub 806 can be in communication with a cloud, as discussedherein. FIG. 19 shows the surgical system 802 being used to perform asurgical procedure on a patient who is lying down on an operating table814 in a surgical operating room 816. The robotic system 810 includes asurgeon's console 818, a patient side cart 820 (surgical robot), and arobotic system surgical hub 822. The robotic system surgical hub 822 isgenerally configured similar to the surgical hub 822 and can be incommunication with a cloud. In some embodiments, the robotic systemsurgical hub 822 and the surgical hub 806 can be combined. The patientside cart 820 can manipulate an intelligent surgical tool 812 through aminimally invasive incision in the body of the patient while a medicalpractitioner, e.g., a surgeon, nurse, and/or other medical practitioner,views the surgical site through the surgeon's console 818. An image ofthe surgical site can be obtained by an imaging device 824 (e.g., theimaging device 120 of FIG. 1 or other imaging device described herein),which can be manipulated by the patient side cart 820 to orient theimaging device 824. The robotic system surgical hub 822 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 818.

A primary display 819 is positioned in the sterile field of theoperating room 816 and is configured to be visible to an operator at theoperating table 814. In addition, as in this illustrated embodiment, avisualization tower 818 can positioned outside the sterile field. Thevisualization tower 818 includes a first non-sterile display 807 and asecond non-sterile display 809, which face away from each other. Thevisualization system 808, guided by the surgical hub 806, is configuredto utilize the displays 807, 809, 819 to coordinate information flow tomedical practitioners inside and outside the sterile field. For example,the surgical hub 806 can cause the visualization system 808 to display asnapshot and/or a video of a surgical site, as obtained by the imagingdevice 824, on one or both of the non-sterile displays 807, 809, whilemaintaining a live feed of the surgical site on the primary display 819.The snapshot and/or video on the non-sterile display 807 and/or 809 canpermit a non-sterile medical practitioner to perform a diagnostic steprelevant to the surgical procedure, for example.

The surgical hub 806 is configured to route a diagnostic input orfeedback entered by a non-sterile medical practitioner at thevisualization tower 818 to the primary display 819 within the sterilefield, where it can be viewed by a sterile medical practitioner at theoperating table 814. For example, the input can be in the form of amodification to the snapshot and/or video displayed on the non-steriledisplay 807 and/or 809, which can be routed to the primary display 819by the surgical hub 806.

The surgical hub 806 is configured to coordinate information flow to adisplay of the intelligent surgical instrument 812, as is described invarious U.S. Patent Applications that are incorporated by referenceherein in the present disclosure. A diagnostic input or feedback enteredby a non-sterile operator at the visualization tower 818 can be routedby the surgical hub 806 to the display 819 within the sterile field,where it can be viewed by the operator of the surgical instrument 812and/or by other medical practitioner(s) in the sterile field.

The intelligent surgical instrument 812 and the imaging device 824,which is also an intelligent surgical tool, is being used with thepatient in the surgical procedure as part of the surgical system 802.Other intelligent surgical instruments 812 a that can be used in thesurgical procedure, e.g., that can be removably coupled to the patientside cart 820 and be in communication with the robotic surgical system810 and the surgical hub 806, are also shown in FIG. 19 as beingavailable. Non-intelligent (or “dumb”) surgical instruments 817, e.g.,scissors, trocars, cannulas, scalpels, etc., that cannot be incommunication with the robotic surgical system 810 and the surgical hub806 are also shown in FIG. 19 as being available for use.

Operating Intelligent Surgical Instruments

An intelligent surgical device can have an algorithm stored thereon,e.g., in a memory thereof, configured to be executable on board theintelligent surgical device, e.g., by a processor thereof, to controloperation of the intelligent surgical device. In some embodiments,instead of or in addition to being stored on the intelligent surgicaldevice, the algorithm can be stored on a surgical hub, e.g., in a memorythereof, that is configured to communicate with the intelligent surgicaldevice.

The algorithm is stored in the form of one or more sets of pluralitiesof data points defining and/or representing instructions, notifications,signals, etc. to control functions of the intelligent surgical device.In some embodiments, data gathered by the intelligent surgical devicecan be used by the intelligent surgical device, e.g., by a processor ofthe intelligent surgical device, to change at least one variableparameter of the algorithm. As discussed above, a surgical hub can be incommunication with an intelligent surgical device, so data gathered bythe intelligent surgical device can be communicated to the surgical huband/or data gathered by another device in communication with thesurgical hub can be communicated to the surgical hub, and data can becommunicated from the surgical hub to the intelligent surgical device.Thus, instead of or in addition to the intelligent surgical device beingconfigured to change a stored variable parameter, the surgical hub canbe configured to communicate the changed at least one variable, alone oras part of the algorithm, to the intelligent surgical device and/or thesurgical hub can communicate an instruction to the intelligent surgicaldevice to change the at least one variable as determined by the surgicalhub.

The at least one variable parameter is among the algorithm's datapoints, e.g., are included in instructions for operating the intelligentsurgical device, and are thus each able to be changed by changing one ormore of the stored pluralities of data points of the algorithm. Afterthe at least one variable parameter has been changed, subsequentexecution of the algorithm is according to the changed algorithm. Assuch, operation of the intelligent surgical device over time can bemanaged for a patient to increase the beneficial results use of theintelligent surgical device by taking into consideration actualsituations of the patient and actual conditions and/or results of thesurgical procedure in which the intelligent surgical device is beingused. Changing the at least one variable parameter is automated toimprove patient outcomes. Thus, the intelligent surgical device can beconfigured to provide personalized medicine based on the patient and thepatient's surrounding conditions to provide a smart system. In asurgical setting in which the intelligent surgical device is being usedduring performance of a surgical procedure, automated changing of the atleast one variable parameter may allow for the intelligent surgicaldevice to be controlled based on data gathered during the performance ofthe surgical procedure, which may help ensure that the intelligentsurgical device is used efficiently and correctly and/or may help reducechances of patient harm by harming a critical anatomical structure.

The at least one variable parameter can be any of a variety of differentoperational parameters. Examples of variable parameters include motorspeed, motor torque, energy level, energy application duration, tissuecompression rate, jaw closure rate, cutting element speed, loadthreshold, etc.

FIG. 20 illustrates one embodiment of an intelligent surgical instrument900 including a memory 902 having an algorithm 904 stored therein thatincludes at least one variable parameter. The algorithm 904 can be asingle algorithm or can include a plurality of algorithms, e.g.,separate algorithms for different aspects of the surgical instrument'soperation, where each algorithm includes at least one variableparameter. The intelligent surgical instrument 900 can be the surgicaldevice 102 of FIG. 1 , the imaging device 120 of FIG. 1 , the surgicaldevice 202 of FIG. 8 , the imaging device 220 of FIG. 8 , the surgicaldevice 402 of FIG. 15 , the surgical device 502 a of FIG. 17 , thesurgical device 502 b of FIG. 17 , the surgical device 712 of FIG. 18 ,the surgical device 812 of FIG. 19 , the imaging device 824 of FIG. 19 ,or other intelligent surgical instrument. The surgical instrument 900also includes a processor 906 configured to execute the algorithm 904 tocontrol operation of at least one aspect of the surgical instrument 900.To execute the algorithm 904, the processor 906 is configured to run aprogram stored in the memory 902 to access a plurality of data points ofthe algorithm 904 in the memory 902.

The surgical instrument 900 also includes a communications interface908, e.g., a wireless transceiver or other wired or wirelesscommunications interface, configured to communicate with another device,such as a surgical hub 910. The communications interface 908 can beconfigured to allow one-way communication, such as providing data to aremote server (e.g., a cloud server or other server) and/or to a local,surgical hub server, and/or receiving instructions or commands from aremote server and/or a local, surgical hub server, or two-waycommunication, such as providing information, messages, data, etc.regarding the surgical instrument 900 and/or data stored thereon andreceiving instructions, such as from a doctor; a remote server regardingupdates to software; a local, surgical hub server regarding updates tosoftware; etc.

The surgical instrument 900 is simplified in FIG. 20 and can includeadditional components, e.g., a bus system, a handle, a elongate shafthaving an end effector at a distal end thereof, a power source, etc. Theprocessor 906 can also be configured to execute instructions stored inthe memory 902 to control the device 900 generally, including otherelectrical components thereof such as the communications interface 908,an audio speaker, a user interface, etc.

The processor 906 is configured to change at least one variableparameter of the algorithm 904 such that a subsequent execution of thealgorithm 904 will be in accordance with the changed at least onevariable parameter. To change the at least one variable parameter of thealgorithm 904, the processor 906 is configured to modify or update thedata point(s) of the at least one variable parameter in the memory 902.The processor 906 can be configured to change the at least one variableparameter of the algorithm 904 in real time with use of the surgicaldevice 900 during performance of a surgical procedure, which mayaccommodate real time conditions.

Additionally or alternatively to the processor 906 changing the at leastone variable parameter, the processor 906 can be configured to changethe algorithm 904 and/or at least one variable parameter of thealgorithm 904 in response to an instruction received from the surgicalhub 910. In some embodiments, the processor 906 is configured to changethe at least one variable parameter only after communicating with thesurgical hub 910 and receiving an instruction therefrom, which may helpensure coordinated action of the surgical instrument 900 with otheraspects of the surgical procedure in which the surgical instrument 900is being used.

In an exemplary embodiment, the processor 906 executes the algorithm 904to control operation of the surgical instrument 900, changes the atleast one variable parameter of the algorithm 904 based on real timedata, and executes the algorithm 904 after changing the at least onevariable parameter to control operation of the surgical instrument 900.

FIG. 21 illustrates one embodiment of a method 912 of using of thesurgical instrument 900 including a change of at least one variableparameter of the algorithm 904. The processor 906 controls 914 operationof the surgical instrument 900 by executing the algorithm 904 stored inthe memory 902. Based on any of this subsequently known data and/orsubsequently gathered data, the processor 904 changes 916 the at leastone variable parameter of the algorithm 904 as discussed above. Afterchanging the at least one variable parameter, the processor 906 controls918 operation of the surgical instrument 900 by executing the algorithm904, now with the changed at least one variable parameter. The processor904 can change 916 the at least one variable parameter any number oftimes during performance of a surgical procedure, e.g., zero, one, two,three, etc. During any part of the method 912, the surgical instrument900 can communicate with one or more computer systems, e.g., thesurgical hub 910, a remote server such as a cloud server, etc., usingthe communications interface 908 to provide data thereto and/or receiveinstructions therefrom.

Situational Awareness

Operation of an intelligent surgical instrument can be altered based onsituational awareness of the patient. The operation of the intelligentsurgical instrument can be altered manually, such as by a user of theintelligent surgical instrument handling the instrument differently,providing a different input to the instrument, ceasing use of theinstrument, etc. Additionally or alternatively, the operation of anintelligent surgical instrument can be changed automatically by analgorithm of the instrument being changed, e.g., by changing at leastone variable parameter of the algorithm. As mentioned above, thealgorithm can be adjusted automatically without user input requestingthe change. Automating the adjustment during performance of a surgicalprocedure may help save time, may allow medical practitioners to focuson other aspects of the surgical procedure, and/or may ease the processof using the surgical instrument for a medical practitioner, which eachmay improve patient outcomes, such as by avoiding a critical structure,controlling the surgical instrument with consideration of a tissue typethe instrument is being used on and/or near, etc.

The visualization systems described herein can be utilized as part of asituational awareness system that can be embodied or executed by asurgical hub, e.g., the surgical hub 706, the surgical hub 806, or othersurgical hub described herein. In particular, characterizing,identifying, and/or visualizing surgical instruments (including theirpositions, orientations, and actions), tissues, structures, users,and/or other things located within the surgical field or the operatingtheater can provide contextual data that can be utilized by asituational awareness system to infer various information, such as atype of surgical procedure or a step thereof being performed, a type oftissue(s) and/or structure(s) being manipulated by a surgeon or othermedical practitioner, and other information. The contextual data canthen be utilized by the situational awareness system to provide alertsto a user, suggest subsequent steps or actions for the user toundertake, prepare surgical devices in anticipation for their use (e.g.,activate an electrosurgical generator in anticipation of anelectrosurgical instrument being utilized in a subsequent step of thesurgical procedure, etc.), control operation of intelligent surgicalinstruments (e.g., customize surgical instrument operational parametersof an algorithm as discussed further below), and so on.

Although an intelligent surgical device including an algorithm thatresponds to sensed data, e.g., by having at least one variable parameterof the algorithm changed, can be an improvement over a “dumb” devicethat operates without accounting for sensed data, some sensed data canbe incomplete or inconclusive when considered in isolation, e.g.,without the context of the type of surgical procedure being performed orthe type of tissue that is being operated on. Without knowing theprocedural context (e.g., knowing the type of tissue being operated onor the type of procedure being performed), the algorithm may control thesurgical device incorrectly or sub-optimally given the particularcontext-free sensed data. For example, the optimal manner for analgorithm to control a surgical instrument in response to a particularsensed parameter can vary according to the particular tissue type beingoperated on. This is due to the fact that different tissue types havedifferent properties (e.g., resistance to tearing, ease of being cut,etc.) and thus respond differently to actions taken by surgicalinstruments. Therefore, it may be desirable for a surgical instrument totake different actions even when the same measurement for a particularparameter is sensed. As one example, the optimal manner in which tocontrol a surgical stapler in response to the surgical stapler sensingan unexpectedly high force to close its end effector will vary dependingupon whether the tissue type is susceptible or resistant to tearing. Fortissues that are susceptible to tearing, such as lung tissue, thesurgical instrument's control algorithm would optimally ramp down themotor in response to an unexpectedly high force to close to avoidtearing the tissue, e.g., change a variable parameter controlling motorspeed or torque so the motor is slower. For tissues that are resistantto tearing, such as stomach tissue, the instrument's algorithm wouldoptimally ramp up the motor in response to an unexpectedly high force toclose to ensure that the end effector is clamped properly on the tissue,e.g., change a variable parameter controlling motor speed or torque sothe motor is faster. Without knowing whether lung or stomach tissue hasbeen clamped, the algorithm may be sub-optimally changed or not changedat all.

A surgical hub can be configured to derive information about a surgicalprocedure being performed based on data received from various datasources and then control modular devices accordingly. In other words,the surgical hub can be configured to infer information about thesurgical procedure from received data and then control the modulardevices operably coupled to the surgical hub based upon the inferredcontext of the surgical procedure. Modular devices can include anysurgical device that is controllable by a situational awareness system,such as visualization system devices (e.g., a camera, a display screen,etc.), smart surgical instruments (e.g., an ultrasonic surgicalinstrument, an electrosurgical instrument, a surgical stapler, smokeevacuators, scopes, etc.). A modular device can include sensor(s)sconfigured to detect parameters associated with a patient with which thedevice is being used and/or associated with the modular device itself.

The contextual information derived or inferred from the received datacan include, for example, a type of surgical procedure being performed,a particular step of the surgical procedure that the surgeon (or othermedical practitioner) is performing, a type of tissue being operated on,or a body cavity that is the subject of the surgical procedure. Thesituational awareness system of the surgical hub can be configured toderive the contextual information from the data received from the datasources in a variety of different ways. In an exemplary embodiment, thecontextual information received by the situational awareness system ofthe surgical hub is associated with a particular control adjustment orset of control adjustments for one or more modular devices. The controladjustments each correspond to a variable parameter. In one example, thesituational awareness system includes a pattern recognition system, ormachine learning system (e.g., an artificial neural network), that hasbeen trained on training data to correlate various inputs (e.g., datafrom databases, patient monitoring devices, and/or modular devices) tocorresponding contextual information regarding a surgical procedure. Inother words, a machine learning system can be trained to accuratelyderive contextual information regarding a surgical procedure from theprovided inputs. In another example, the situational awareness systemcan include a lookup table storing pre-characterized contextualinformation regarding a surgical procedure in association with one ormore inputs (or ranges of inputs) corresponding to the contextualinformation. In response to a query with one or more inputs, the lookuptable can return the corresponding contextual information for thesituational awareness system for controlling at least one modulardevice. In another example, the situational awareness system includes afurther machine learning system, lookup table, or other such system,which generates or retrieves one or more control adjustments for one ormore modular devices when provided the contextual information as input.

A surgical hub including a situational awareness system may provide anynumber of benefits for a surgical system. One benefit includes improvingthe interpretation of sensed and collected data, which would in turnimprove the processing accuracy and/or the usage of the data during thecourse of a surgical procedure. Another benefit is that the situationalawareness system for the surgical hub may improve surgical procedureoutcomes by allowing for adjustment of surgical instruments (and othermodular devices) for the particular context of each surgical procedure(such as adjusting to different tissue types) and validating actionsduring a surgical procedure. Yet another benefit is that the situationalawareness system may improve surgeon's and/or other medicalpractitioners' efficiency in performing surgical procedures byautomatically suggesting next steps, providing data, and adjustingdisplays and other modular devices in the surgical theater according tothe specific context of the procedure. Another benefit includesproactively and automatically controlling modular devices according tothe particular step of the surgical procedure that is being performed toreduce the number of times that medical practitioners are required tointeract with or control the surgical system during the course of asurgical procedure, such as by a situationally aware surgical hubproactively activating a generator to which an RF electrosurgicalinstrument is connected if it determines that a subsequent step of theprocedure requires the use of the instrument. Proactively activating theenergy source allows the instrument to be ready for use a soon as thepreceding step of the procedure is completed.

For example, a situationally aware surgical hub can be configured todetermine what type of tissue is being operated on. Therefore, when anunexpectedly high force to close a surgical instrument's end effector isdetected, the situationally aware surgical hub can be configured tocorrectly ramp up or ramp down a motor of the surgical instrument forthe type of tissue, e.g., by changing or causing change of at least onevariable parameter of an algorithm for the surgical instrument regardingmotor speed or torque.

For another example, a type of tissue being operated can affectadjustments that are made to compression rate and load thresholds of asurgical stapler for a particular tissue gap measurement. Asituationally aware surgical hub can be configured to infer whether asurgical procedure being performed is a thoracic or an abdominalprocedure, allowing the surgical hub to determine whether the tissueclamped by an end effector of the surgical stapler is lung tissue (for athoracic procedure) or stomach tissue (for an abdominal procedure). Thesurgical hub can then be configured to cause adjustment of thecompression rate and load thresholds of the surgical staplerappropriately for the type of tissue, e.g., by changing or causingchange of at least one variable parameter of an algorithm for thesurgical stapler regarding compression rate and load threshold.

As yet another example, a type of body cavity being operated in duringan insufflation procedure can affect the function of a smoke evacuator.A situationally aware surgical hub can be configured to determinewhether the surgical site is under pressure (by determining that thesurgical procedure is utilizing insufflation) and determine theprocedure type. As a procedure type is generally performed in a specificbody cavity, the surgical hub can be configured to control a motor rateof the smoke evacuator appropriately for the body cavity being operatedin, e.g., by changing or causing change of at least one variableparameter of an algorithm for the smoke evacuator regarding motor rate.Thus, a situationally aware surgical hub may provide a consistent amountof smoke evacuation for both thoracic and abdominal procedures.

As yet another example, a type of procedure being performed can affectthe optimal energy level for an ultrasonic surgical instrument or radiofrequency (RF) electrosurgical instrument to operate at. Arthroscopicprocedures, for example, require higher energy levels because an endeffector of the ultrasonic surgical instrument or RF electrosurgicalinstrument is immersed in fluid. A situationally aware surgical hub canbe configured to determine whether the surgical procedure is anarthroscopic procedure. The surgical hub can be configured to adjust anRF power level or an ultrasonic amplitude of the generator (e.g., adjustenergy level) to compensate for the fluid filled environment, e.g., bychanging or causing change of at least one variable parameter of analgorithm for the instrument and/or a generator regarding energy level.Relatedly, a type of tissue being operated on can affect the optimalenergy level for an ultrasonic surgical instrument or RF electrosurgicalinstrument to operate at. A situationally aware surgical hub can beconfigured to determine what type of surgical procedure is beingperformed and then customize the energy level for the ultrasonicsurgical instrument or RF electrosurgical instrument, respectively,according to the expected tissue profile for the surgical procedure,e.g., by changing or causing change of at least one variable parameterof an algorithm for the instrument and/or a generator regarding energylevel. Furthermore, a situationally aware surgical hub can be configuredto adjust the energy level for the ultrasonic surgical instrument or RFelectrosurgical instrument throughout the course of a surgicalprocedure, rather than just on a procedure-by-procedure basis. Asituationally aware surgical hub can be configured to determine whatstep of the surgical procedure is being performed or will subsequentlybe performed and then update the control algorithm(s) for the generatorand/or ultrasonic surgical instrument or RF electrosurgical instrumentto set the energy level at a value appropriate for the expected tissuetype according to the surgical procedure step.

As another example, a situationally aware surgical hub can be configuredto determine whether the current or subsequent step of a surgicalprocedure requires a different view or degree of magnification on adisplay according to feature(s) at the surgical site that the surgeonand/or other medical practitioner is expected to need to view. Thesurgical hub can be configured to proactively change the displayed view(supplied by, e.g., an imaging device for a visualization system)accordingly so that the display automatically adjusts throughout thesurgical procedure.

As yet another example, a situationally aware surgical hub can beconfigured to determine which step of a surgical procedure is beingperformed or will subsequently be performed and whether particular dataor comparisons between data will be required for that step of thesurgical procedure. The surgical hub can be configured to automaticallycall up data screens based upon the step of the surgical procedure beingperformed, without waiting for the surgeon or other medical practitionerto ask for the particular information.

As another example, a situationally aware surgical hub can be configuredto determine whether a surgeon and/or other medical practitioner ismaking an error or otherwise deviating from an expected course of actionduring the course of a surgical procedure, e.g., as provided in apre-operative surgical plan. For example, the surgical hub can beconfigured to determine a type of surgical procedure being performed,retrieve a corresponding list of steps or order of equipment usage(e.g., from a memory), and then compare the steps being performed or theequipment being used during the course of the surgical procedure to theexpected steps or equipment for the type of surgical procedure that thesurgical hub determined is being performed. The surgical hub can beconfigured to provide an alert (visual, audible, and/or tactile)indicating that an unexpected action is being performed or an unexpecteddevice is being utilized at the particular step in the surgicalprocedure.

In certain instances, operation of a robotic surgical system, such asany of the various robotic surgical systems described herein, can becontrolled by the surgical hub based on its situational awareness and/orfeedback from the components thereof and/or based on information from acloud (e.g., the cloud 713 of FIG. 18 ).

Embodiments of situational awareness systems and using situationalawareness systems during performance of a surgical procedure aredescribed further in previously mentioned U.S. patent application Ser.No. 16/729,772 entitled “Analyzing Surgical Trends By A Surgical System”filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,747entitled “Dynamic Surgical Visualization Systems” filed Dec. 30, 2019,U.S. patent application Ser. No. 16/729,744 entitled “VisualizationSystems Using Structured Light” filed Dec. 30, 2019, U.S. patentapplication Ser. No. 16/729,778 entitled “System And Method ForDetermining, Adjusting, And Managing Resection Margin About A SubjectTissue” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,729entitled “Surgical Systems For Proposing And Corroborating Organ PortionRemovals” filed Dec. 30, 2019, U.S. patent application Ser. No.16/729,778 entitled “Surgical System For Overlaying Surgical InstrumentData Onto A Virtual Three Dimensional Construct Of An Organ” filed Dec.30, 2019, U.S. patent application Ser. No. 16/729,751 entitled “SurgicalSystems For Generating Three Dimensional Constructs Of Anatomical OrgansAnd Coupling Identified Anatomical Structures Thereto” filed Dec. 30,2019, U.S. patent application Ser. No. 16/729,740 entitled “SurgicalSystems Correlating Visualization Data And Powered Surgical InstrumentData” filed Dec. 30, 2019, U.S. patent application Ser. No. 16/729,737entitled “Adaptive Surgical System Control According To Surgical SmokeCloud Characteristics” filed Dec. 30, 2019, U.S. patent application Ser.No. 16/729,796 entitled “Adaptive Surgical System Control According ToSurgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S.patent application Ser. No. 16/729,803 entitled “Adaptive VisualizationBy A Surgical System” filed Dec. 30, 2019, and U.S. patent applicationSer. No. 16/729,807 entitled “Method Of Using Imaging Devices InSurgery” filed Dec. 30, 2019.

Surgical Sealing Devices for a Natural Body Orifice

In certain embodiments, surgical sealing devices are provided that areconfigured to allow surgical access into a body cavity through a naturalbody orifice (e.g., a trachea, a rectum, and the like). In general, thepresent surgical sealing devices include a seal housing that isconfigured to be at least partially disposed within a natural bodyorifice and at least one retention element configured to affix the sealhousing to the natural body orifice. Unlike conventional surgicalsealing devices that are typically inserted into an incision, thepresent surgical sealing devices are designed to be inserted into anatural body orifice. As a result, the present surgical sealing devicesprovide a less traumatic and more direct access point to a natural bodylumen or organ (e.g., for introduction and extraction of surgicalinstruments, fluid exchange, breathing apparatuses, smoke evacuationapparatuses, etc.) that would not otherwise be available through the useof conventional surgical sealing devices.

In use, as discussed in more detail below, the surgical sealing devicesdisclosed herein can be used to provide access to a natural body lumen,such as a colon, through a natural body orifice associated therewith.That is, the seal housing can be at least partially positioned within anatural body orifice. Given the contractive nature of a natural bodyorifice, however, it can be difficult maintain the seal housing withinthe natural body office. As a result, the surgical sealing devicesinclude at least one retention element (e.g., arranged on an exteriorsurface of the seal housing) that enables and maintains fixation of theseal housing to the natural body orifice during device use. The at leastone retention element can be configured to be deployed inside or outsideof the patient's body.

The seal housing can be positioned and affixed to the natural bodyorifice in such a way in which a distal portion of the seal housingextends into the natural body orifice, and a proximal portion extendsout of the natural body orifice and into the ambient environment (e.g.,positioned adjacent to and in contact with an exterior surface of thepatient's body, such as the patient's skin. Alternatively, the sealhousing can be designed to be entirely positioned within the naturalbody orifice.

Further, the seal housing generally includes one or more ports arrangedwithin the seal housing to allow instruments to pass into the naturalbody lumen from the ambient environment through the natural bodyorifice. The one or more ports arranged through the seal housing canform pathway(s) into and through the natural body orifice. This canenable controlled fluid exchange through the natural body orifice, andconsequently, into and/or out of the natural body lumen associatedtherewith, introduction and extraction of surgical instruments throughthe natural body orifice, and the like. As a result, the natural bodylumen can be accessed without the need for an incision through thepatient's skin.

FIG. 22 and FIG. 23 illustrate one embodiment of a surgical sealingdevice 7000 that is configured to provide access into a natural bodylumen or organ (e.g., a lung, a stomach, a colon, or small intestines)through a natural body orifice (e.g., esophagus, rectum, and the like).Therefore, at least a portion of the surgical sealing device 7000 isconfigured to be inserted into and stabilized within a natural bodyorifice.

The sealing device 7000 includes a seal housing 7100 with portsextending therethrough and at least one retention element on theexterior surface 7101 of the seal housing 7100. While the at least oneretention element can have a variety of configurations, in thisillustrated embodiment, the at least one retention element includesfirst retention elements 7130 and second retention elements 7132. Thefirst and second retention elements 7130, 7132 are configured to securethe seal housing 7100 within a natural body orifice.

In use, the surgical sealing device 7000 can be positioned within anatural body orifice, such as by deforming the seal housing 7100, or aportion thereof (e.g., the outer body member 7104) and inserting theseal housing 7100 in the natural body orifice. The insertion of the sealhousing can be performed by hand or by using an insertion tool. The atleast one retention element is releasably positioned to thereby affixthe seal housing to the natural body orifice. In some embodiments, theat least one retention element can be deployed inside the natural bodylumen, whereas in other embodiments, the at least one retention elementcan be deployed outside of the natural body lumen. The at least oneretention member can be releasably positioned concurrently with orsubsequently after the sealing housing is positioned at least partiallywithin the natural body lumen. To withdraw the surgical sealing device7000 from the natural body orifice, a portion of the seal housing 7100(e.g., the outer body member 7104) can be gripped with one or both hands(such as at opposite sides of the outer body member 7104) or by aremoval instrument, or both, and the seal housing 7100 may be pulledproximally to withdraw the seal housing 7100 from natural body orifice.Prior to gripping the seal housing, the at least one retention elementcan be moved or otherwise disengaged from tissue defining the naturalbody orifice or tissue positioned proximate to the natural body orifice.

As shown in FIG. 22 and FIG. 23 , the first and second retentionelements 7130, 7132 are arranged on and extend from the exterior surface7101 of the seal housing 7100. The first and second retention elements7130, 7132 can have a variety of configurations. In some embodiments,the first and second retention elements can have the same or similarconfigurations. In other embodiments, the first and second retentionelements can have different structural configurations relative to eachother. It is also contemplated herein that in certain embodiments, thefirst retention elements or the second retention elements can beomitted.

In this illustrated embodiment, the first and second retention elements7130, 7132 are each in the form of barbs that are configured topenetrate into the tissue to affix the seal housing 7100 to the naturalbody orifice. Further, the retention elements 7130, 7132 can allow fortwisting and deformation of the natural body orifice, which can occurnaturally, while also keeping the seal housing 7100 securely lodgedwithin the natural body orifice.

In other embodiments, the at least one retention element can have astructural configuration that is configured to contact and engage thetissue surrounding or adjacent to the natural body orifice withoutpenetration. That is, the at least one retention element can have astructural configuration that is configured to frictionally engage withthe tissue so to prevent the seal housing from further movement withinthe natural body orifice during use. By way of example, in someembodiments, the at least one retention element can be in the form of anexpandable element (e.g., inflatable balloons), as illustrated in FigureX. In use, once the seal housing is inserted (e.g., partially or fully)within the natural body orifice, the expandable element(s) can beinflated, and when the seal housing is to be removed from the naturalbody orifice, the expandable element(s) can be deflated.

In some embodiments, when one or more retention elements are expandableelements, these retention elements can configured to be expanded withinthe natural body orifice (e.g., after at least a portion of the sealhousing is inserted into the natural body orifice). In other embodimentsone or more retention elements can be configured to be deployed outsideof the natural body lumen (e.g., after at least a portion of the sealhousing is inserted into the natural body orifice). Alternatively, incertain embodiments, at least one retention element can be configured tobe deployed within the natural body orifice, and at least another oneretention element can be configured to be deployed outside the naturalbody orifice. A person skilled in the art will appreciate that thedeployable position of the retention elements depends at least upon theposition of the retention elements relative to the seal housing 7100 andthe position of the seal housing 7100 relative to the natural bodyorifice when the seal housing 7100 is inserted therein.

FIG. 24 illustrates an exemplary embodiment of a surgical sealing device7400 that includes a sealing housing 7402 and two retention elements7404, 7406 that are in the form of inflatable balloons. The tworetention elements 7404, 7406 are each configured to move from anunexpanded to an expanded state (FIG. 24 ). Aside from the differencesdescribed in detail below, sealing device 7400 can be similar to sealingdevice 7000 (FIG. 22 and FIG. 23 ) and therefore common features are notdescribed in detail herein. As shown, the first retention element 7404is positioned at a first end 7202 a of the seal housing 7402 and thesecond retention element 7406 is positioned at a second end 7202 b ofthe seal housing 7402. Further, when both the first and second retentionelements 7404, 7406 are in their expanded state, as illustrated in FIG.24 , they are configured to contact and frictionally engage an internalsurface of the natural body orifice. In embodiments where only a portionof the surgical sealing device 7400 is positioned within the naturalbody orifice, the second end 7402 b of the seal housing 7402 can bepositioned outside the natural body orifice (e.g., outside of the bodyof the patient). In such embodiments, the second retention element 7406can be configured to contact and frictionally engage the outer tissuesurface surrounding or adjacent to the natural body orifice (e.g., anexternal surface of the natural body orifice).

Referring back to FIG. 22 and FIG. 23 , the seal housing 7100 ofsurgical sealing device 7000 can have a variety of configurations. Forexample, in this illustrated embodiment, the seal housing 7100 has aninner body member 7102 and an outer body member 7104 that is positionedabout the inner body member 7102. In other embodiments, the outer bodymember can designed so as to extend distally from one end of the innerbody member. In certain embodiments, the outer body member can beomitted.

The inner body member 7102 and the outer body member 7104 can each havea variety of configurations. In this illustrated embodiment, the innerbody member 7102 has a generally cylindrical configuration. The outerbody member 7104 includes an annular flange 7106 with an elongatedcylindrical base 7110 extending therefrom. Further, the base 7110defines a lumen 7112 extending therethrough. The lumen 7112, as shown inFIG. 22 and FIG. 23 , at least partially houses the inner body member7102. A person skilled in the art will appreciate that the inner bodymember and/or the outer body member, and/or portions thereof, can haveother suitable shapes and sizes (e.g., oval, elliptical, ovoid, and anycombination thereof) and therefore their configurations are not limitedto what is shown in the figures.

The inner body member 7102 and the outer body member 7104 can formed asa unitary structure, permanently coupled to each other, or releasablycoupled to each other. For example, in some embodiments, the inner bodymember 7102 can be configured to be inserted into and/or removed fromthe lumen 7112 (e.g., while the outer body member 7104 is at leastpartially positioned within a natural body orifice). In certainembodiments, the outer body member 7104 can be configured to provideassistance in preventing the inner body member 7102 from be pushedthrough the sealing housing 7100 (e.g., and into the body of thepatient), and to assist in removing the inner body member 7102 from theseal housing 7100. For example, during surgery, removal of the innerbody member 7102 may be needed for removing damaged or diseased tissuethrough the lumen 7112 of the outer body member 7104. Further, inaddition, or alternatively, the outer body member 7104 can be configuredto help prevent the inner body member 7102 from being torn or otherwisedamaged by surgical instrument(s) that is/are inserted therethrough(e.g., during surgery).

As further shown in FIG. 22 and FIG. 23 , the inner body member 7102includes ports that extend therethrough, and thus, through the sealhousing 7100. While the inner body 7102 can include two or more ports,in this illustrated embodiment the inner body member 7102 includes threeports: a first port 7114, a second port 7116, a third port 7118. Eachport 7114, 7116, 7118 defines a respective passageway 7120, 7122, 7124through the seal housing 7100. The ports 7114, 7116, 7118 can bedesigned as a variety of different ports that serve different functions(e.g., fluid exchange into and/or out of the natural body lumen, sealinginstruments inserted therethrough, preventing fluid from escaping out ofthe natural body orifice and into the ambient environment, and/or thelike).

In some embodiments, at least one port can be configured to form a seal(e.g., around an instrument inserted therethrough) and at least anotherone port can be configured to control the ingress and/or egress of fluid(e.g., liquid, gas, or a combination thereof) between an interior volumeof the natural body orifice and an ambient environment. In certainembodiments, at least one port can be configured to seal and controlingress and/or egress of fluid. For purposes of this discussion, thefirst and second ports 7114, 7116 are each configured to form arespective seal around an instrument inserted therethrough and the thirdport 7118 is configured to control the fluid ingress and egress. Aperson skilled in the art that any of these ports can configured tocontrol fluid ingress and/or egress (e.g., air into and/or out of thenatural body orifice, e.g., for breathing or insufflation) and/or toform a seal (e.g., around an instrument inserted therethrough and/orwhen an instrument is absent, for preventing loss of fluidtherethrough).

In some embodiments, sealing element(s) can be positioned within thefirst port and/or second port to form a seal therein. In someembodiments, the sealing element(s) can be in the form of a thinmembrane formed of a flexible material which can be punctured orotherwise pierced by a surgical instrument. In addition, oralternatively, zero closure sealing elements such as a duck bill seal orother suitable seals for sealing in the absence of instrument can beused in association with the ports. The sealing elements can bepositioned at any suitable location within the port.

As shown in FIG. 22 and FIG. 23 , a first sealing element 7126 ispositioned within the passageway 7120 of the first port 7114 and asecond sealing element 7128 is positioned within the passageway of thesecond port 7116. In some embodiments, the first and second sealingelements 7126, 7128 can the same, whereas in other embodiments, thefirst and second sealing elements 7126, 7128 can be different. The firstand second sealing elements 7126, 7128 can be positioned in a variety ofdifferent locations within the respective passageways. In thisillustrated embodiment, the first sealing element 7126 is positionedproximate to the proximal end 7114 p (e.g., the end closest to theambient environment during use) of the first port and the second sealingelement 7128 is positioned proximate to the proximal end 7116 p (e.g.,the end closest to the ambient environment during use) of the secondsealing port 7116. In other embodiments, the first sealing element, thesecond sealing element, or both, can be positioned at a distal end ofthe second port and the third port, respectively.

In some embodiments, the first sealing element 7126, the second sealingelement 7128, or both can be further configured to limit the directionof airflow while also providing sealed access for the surgicalinstruments through the seal housing 7100. This can preventcontamination from aerosolized viruses or contagions during treatmentdue to the advancement and extraction of surgical instruments throughthe first port 7114 and/or the second port 7116. Additionally, the firstsealing element, the second sealing element, or both can be a one-wayvalve to allow exhaust to be vented to a fluid trap and particulatefilter to control the expiration of contagions. In another exemplaryembodiment, the surgical sealing device 7000 can have a small higherpressure inlet and a larger exhaust port for controlling exhaust gasesbeing expelled from the natural body lumen.

In addition to the insertion and extraction of one or more surgicalinstruments through the first and second ports 7114, 7116, fluidexchange can occur through the third port 7118 of the surgical sealingdevice 7000. That is, in this illustrated embodiment, the third port7118 is designed to allow the ingress and egress of fluid between aninterior volume of the natural body orifice and an ambient environment.

In certain embodiments, as shown in FIG. 22 , the third port 7118 can beoperatively connected to a valve 7210. The valve 7210 can be configuredto monitor a parameter that can be used to control a fluid transfer ratethrough the third port 7118. The monitored parameter can be a fluidtransfer pressure, a fluid transfer volume, and/or a direction of thefluid transfer therethrough. For example, the valve can include a sensorthat is configured to sense the pressure, volume, or flow direction ofthe fluid as it passes through the valve, and transmit the sensed datato a controller (not shown). If at any time during use, the controllerdetermines that the sensed data is outside of a predetermined range(s),the controller can alter the valve position (e.g., partially close oropen the valve relative to its current position) to change the pressure,volume, or flow direction of the fluid therethrough, and consequently,through the third port 7118. Non-limiting examples of suitable sensorsinclude pressure, temperature, and flow sensors. In other embodiments, acontroller can be omitted, and the valve can be structurally configuredto control the fluid flow therethrough by itself, and therefore alterthe pressure, volume, or flow direction, if needed.

During an electrosurgical procedure, energy devices can deliverymechanical and/or electrical energy to target tissue in order to treatthe tissue (e.g., to cut the tissue, cauterize blood vessels and/orcoagulate the tissue within and/or near the targeted tissue). Thecutting, cauterization, and/or coagulation of tissue can result influids and/or particulates being released into the air. Such fluidsand/or particulates emitted during a surgical procedure can constitutesmoke, for example, which can comprise carbon particles and/or otherparticles suspended in air. As a result, electrosurgical systemstypically employ a surgical evacuation system that captures theresultant smoke from a surgical procedure, and directs the capturedsmoke through a filter and a smoke exhaust port away from theclinician(s) and/or from the patient(s).

For example, surgical procedures on a lung can require inhalation andexpulsion of breathable air and exhaustion of smoke that is generatedduring the procedure. In such instances, cooperative control of thesmoke evaluation and breathing apparatus can be helpful. As such, thesurgical sealing devices disclosed herein can be configured to enablesimultaneous trans-seal system use. That is, the present surgicalsealing devices can be configured to provide smoke evacuation control ofa fluid exchange system that allows cooperative flow of fluid such that,during surgery, the body can continue to receive the intended flow offluid (e.g., breathable air) while also allowing extraction of a portionof the fluid through a different path to direct the smoke extractionfrom the patient.

In some embodiments, the smoke exhaust port can be its own separate portwithin the seal housing or it can be combined with another port of theseal housing (e.g., a port that is connected to a breathing apparatusthat inflates and deflates the lung with breathable air and/orconfigured for insertion and extraction of surgical instruments), or thesmoke evacuator passage can be a working passage of a flexible endoscopeinserted through a port of the seal housing for controlling the ingressand egress of lung gasses as needed for breathing and smoke evacuation.If the smoke evacuation is activated when the body is breathing, anadditional airflow inlet can be configured as a port of the seal housingto offset the smoke evacuation air flow, resulting in enough air forlung inflation while cooperatively extracting smoke and air form thelung. In some embodiments, the smoke evacuation system can be configuredto pass the smoke to an externally connected smoke evacuator pump andfilters, while in other embodiments, the smoke evacuation system can bearranged to use the same filters as a primary breathing exhaust systemcoupled to the breathing passage port of the seal housing. Exemplarysmoke evacuator systems suitable for use with the present disclosure aredescribed, for example, in U.S. Pat. No. 11,051,876 entitled “SurgicalEvacuation Flow Paths” issued Jul. 6, 2021, U.S. Patent Publication No.2019/0201088 entitled “Surgical Evacuation System With A CommunicationCircuit For Communication Between A Filter And A Smoke EvacuationDevice” published Jul. 4, 2019, and U.S. Patent Publication No.2019/0204201 entitled “Adjustments Based On Airborne ParticleProperties” published Jul. 4, 2019, the disclosures of which areincorporated herein by reference in their entireties.

FIG. 25 illustrates another embodiment of a surgical sealing device7300. Aside from the differences described in detail below, the surgicalsealing device 7300 can be similar to surgical sealing device 7000 (FIG.22 and FIG. 23 ) and therefore common features are not described indetail herein. The surgical sealing device 7300 is shown at leastpartially inserted within a natural body orifice 10 formed by tissue 12.The surgical sealing device 7300 includes a seal housing 7301 having aninner body member 7302 and an outer body member 7304 that is positionedabout the inner body member 7302. The inner body member 7302 has threeports 7306, 7308, 7310 extending therethrough. While different numbersand sizes of ports can be used, the illustrated three ports 7306, 7308,7310 include one relatively larger port 7306 (e.g., to receive anendoscope or other relatively larger diameter device), and tworelatively smaller ports 7308, 7310 (e.g., to receive relatively smallerdevices, such as graspers, clip appliers, or the like).

Further, the seal housing 7301 includes first retention elements 7312and second retention elements 7314. As shown, the first retentionelements 7312 extend outward from the elongated cylindrical base 7316 ofthe outer body member 7304 and the second retention elements 7314 extendfrom a bottom surface 7318a of the annular flange 7318 of the outer bodymember 7304. The first retention elements 7312 engage with an internalsurface 7320 of the natural body orifice 10 and penetrate portions ofthe tissue 12 that define such internal surface 7320. Since the surgicalsealing device 7300 is only partially inserted into the natural bodyorifice 10, the annular flange 7318 of the seal housing 7300 ispositioned outside of the natural body orifice 10. As a result, thesecond retention elements 7314 engage an outer tissue surface 7322surrounding the natural body orifice 10 and penetrate portions of thetissue 12 that define such outer surface 7322 (e.g., external surface ofthe natural body lumen). This penetration by both the first and secondretention elements 7312, 7314 into the tissue 12 affix the seal housing7301 to the natural body orifice 10 so as to allow one or more surgicalinstruments to be inserted and extracted through the natural bodyorifice 10 and/or fluid transfer to occur through the natural bodyorifice 10.

In some embodiments, the surgical sealing device can include woundprotectors for use with natural body orifices that enable introductionand extraction of instruments while limiting instrument to tissueinteraction. This limiting of interaction between the tissue andinstruments can provide reduced friction between the body wall and theinsertion forces of the instruments. The arrangement can minimize damageto the surrounding tissue during manipulation or advancing or retractingof the instruments through the sealing device.

In some embodiments, the seal housing of the surgical sealing device canbe configured as a mechanical fixation point for a flexible scope and/orinstruments passing through the seal housing. The seal housing can bearranged such that a fixation point is formed by the seal housing beingsecured within the natural body orifice, which provides the flexiblescope and/or instruments passing through the seal housing a resistivefixation point from which to resist internally generated forces, motionsand actions from the instruments manipulating tissue within the body.The fixation point for the instruments would prevent inappropriate loadson the patient during movement of the instruments within the sealingdevice. The fixation point could be outside of the body and preventexcessive torque from being applied to the body by the instrumentsthrough the sealing device.

While the seal housings 7100, 7402, 7301 in FIG. 22 and FIG. 23 , FIG.24 , and FIG. 25 are illustrated as a separate device which to beinserted into a natural body orifice and allows instruments to beinserted therethrough and into a natural body lumen, in otherembodiments a seal housing can be arranged on an instrument, such as agastroscopic bougie, as the instrument is inserted into a natural bodyorifice. A gastroscopic bougie is commonly understood to be a thincylinder of rubber, plastic, metal or another material that a medicalpractitioner inserts into or through a body passageway, such as theesophagus, to diagnose or treat a condition. A bougie may be used towiden a passageway, guide another instrument into a passageway, ordislodge an object. The gastroscopic bougie can include a seal housinghaving retention elements which are configured to be deployed in theesophagus prior to the stomach. This arrangement would allowlaparoscopic access to the stomach while the abdominal cavity isinsufflated for procedures such as a tumor resection within the stomach.By arranging the seal housing in the esophagus, the laparoscopicinsufflation is prevented from escaping endoluminally, while alsoallowing bougie to manipulate the stomach and tumor through four-wirecontrol.

Surgical Systems with Port Devices for Instrument Control

In certain embodiments, surgical systems that enable control of surgicalinstrument interactions between separate port devices are provided. Ingeneral, these systems have two or more port devices (e.g., multi-portdevices) that include respective housings that are each configured toallow instruments from respective sets of instruments to be insertedtherethrough. The two or more port devices are each designed to provideindividualized resistive forces to respective inserted instruments andto allow the inserted instruments to work cooperatively together (e.g.,for at least one surgical step of a surgical procedure or at one or moresurgical sites, etc.). The two or more port devices are interconnectedto each other (e.g., electrically or mechanically) to create aninterrelationship between the inserted instruments. Thisinterrelationship enables these instruments to work in combination(e.g., move concurrently or sequentially in the same or differentdirection relative to each other or in groups) to provide the force(s),retraction, access angle(s), and the like to carry out at least onesurgical step (e.g., to provide the intended medial therapy). As aresult, these cooperative movements between at least a portion of theinserted instruments can provide a more collaborative surgicalenvironment within the same port or among different ports that canincrease precision and help prevent collisions (e.g., of surgicalinstruments and/or robotic arms).

A person skilled in the art will understand that the phrase “workcooperatively together” as used herein refers to coordinated movementbetween two or more inserted instruments in the same port, in separateports, or a combination thereof based on a location, an orientation, ora motion of at least one inserted instrument of the two or more insertedinstruments. Similarly, a person skilled in the art will understand thatthe coordinated movement between the two or more inserted instrumentscan occur in the same direction at the same time, in the same directionat different times, opposing directions at the same time, opposingdirections at different times, in the same plane at the same time, inthe same plane at different times, in two separate planes at the sametime, in two different planes at different times, or any combinationthereof.

Each port device is configured to be at least partially disposed with abody. For example, a first port device can be partially inserted into abody (e.g., through a natural orifice or an opening made by an incision)and a second port device can be partially inserted into the (e.g.,through a natural orifice or an opening made by an incision). The firstand second port devices can be partially inserted within the samephysiological space or different physiological spaces. In someembodiments, the first port device can bridge the ambient environmentwith a first physiological space inside the body (e.g., thoracic cavityor abdomen cavity and the second port device can bridge the ambientenvironment and a second physiological space that is not directlyconnected to the first physiological space (e.g., through a naturalorifice to inside the colon, esophagus or other physiologic tract). Inother embodiments, the first and second physiological spaces aredirectly connected to each other. For example, in one embodiment, thefirst port device can be partially inserted into a first abdominalquadrant and the second port device can be partially inserted into asecond abdominal quadrant that is different than the first abdominalquadrant.

The housing of each port device can be positioned and affixed to body insuch a way in which a distal portion of the housing extends into thebody (e.g., a physiological space), and a proximal portion extends outof the body and into the ambient environment (e.g., positioned adjacentto and in contact with an exterior surface of the patient's body, suchas the patient's skin). Alternatively, the housing can be designed to beentirely positioned within the body.

Further, the housing of each port device generally includes portsarranged within the housing that allow instruments to be insertedtherethrough into the body (e.g., a physiological space, such as a oneor more cavities within the body) from the ambient environment through anatural body orifice or an opening made by an incision. The portsarranged through the housing can form pathway(s) into and through thebody.

In some embodiments, at least one port of at least one port device canbe configured to form a seal around an inserted instrument. In oneembodiment, at least one port of the first port device can be configuredto form a seal around a respective inserted instrument of a first set ofinstruments. Alternatively, or in addition, at least one port of thesecond port device can be configured to form a seal around a respectiveinserted instrument of a second set of instruments.

In certain embodiments, sealing element(s) can be positioned within theat least one port to form a seal therein. The sealing element(s) canhave a variety of configurations. In some embodiments, the sealingelement(s) can be in the form of a thin membrane formed of a flexiblematerial which can be punctured or otherwise pierced by a surgicalinstrument. Alternatively, or in addition, zero closure sealing elementssuch as a duck bill seal or other suitable seals for sealing in theabsence of instrument can be used in association with the at least oneport. The sealing elements can be positioned at any suitable locationwithin the at least one port.

In some embodiments, when first and second instruments are inserted intorespective ports of the first port device, the first port device can beconfigured to allow the first instrument to move within a first range ofmotion relative to the first port device and to allow the secondinstrument to move within a second range of motion relative to the firstport device that is at least partially overlaps with the first range ofmotion. Alternatively, or in addition, when first and second instrumentsare inserted into respective ports of the second port device, the secondport device can be configured to allow the first instrument to movewithin a first range of motion relative to the second port device and toallow the second instrument to move within a second range of motionrelative to the second port device that at least partially overlaps withthe first range of motion.

In use, as discussed in more detail below, the respective port deviceprovides resistive inter-device forces to respective insertedinstruments (e.g., to prevent unintended contact between insertedinstruments). That is, during movement of an inserted instrument, theport device can restrain movement of the inserted instrument relative toother inserted instruments in the same port device, in at least oneother port device, or a combination thereof. The port device(s) of thesurgical system are configured to interact at least one insertedinstrument in such a way that limits one or more instrument motions.This limitation can be based on, for example, at least one of alocation, orientation, and a motion of at least one other instrument ofthe same set of inserted instruments, at least one other instrument of adifferent set of inserted instruments, or both.

The location, orientation, motion, or any combination thereof, of aninserted instrument can be determined, for example, by using one or moretracking device(s) or a tracking system. In some embodiments, the systemcan include a tracking device that can be associated with one of thefirst port device or the second port device. The tracking device can beconfigured in a variety of ways. In certain embodiments, the trackingdevice can be configured to transmit a signal indicative of a locationof the first port device relative to the second port device.Alternatively, or in addition, the tracking device can be configured totransmit a signal indicative of at least one of a location, anorientation, and a motion of at least one inserted instrument in thefirst port device relative to the second port device. Alternatively, orin addition, the tracking device can be configured to transmit a signalindicative of at least one of a location, an orientation, and a motionof at least one inserted instrument in the second port device relativeto the first port device.

The transmitted signal(s) from the tracking device can be received by acontroller. In general, depending on the data of the received signal,the controller can determine at least one or more of the following: arelative location of the first port device and the second port device,at least one of the location, the orientation, and the motion of atleast one inserted instrument in the first port device relative to thesecond port device, or at least one of the location, the orientation,and the motion of the at least one inserted instrument of in the secondport device relative to the first port device based on the respectivetransmitted signal. This information is used as guidance for movement ofthe inserted instruments individually, as a single group, or as multiplegroups. This guidance in combination with the resistive forces appliedby the respective port devices can control instrument interactionbetween the inserted instruments such that the inserted instruments canwork cooperatively together at one or more surgical sites and/or toperform at least one surgical step of a surgical procedure.

An exemplary surgical system can include a variety of features asdescribed herein and illustrated in the drawings. However, a personskilled in the art will appreciate that the surgical systems can includeonly some of these features and/or it can include a variety of otherfeatures known in the art. The surgical systems described herein aremerely intended to represent certain exemplary embodiments. Moreover,while the surgical systems are shown and described in connection with acolon, a person skilled in the art will appreciate that these surgicalsystems can be used in connection with any other suitable natural bodylumens or organs.

Surgery is often the primary treatment for early-stage colon cancers.The type of surgery used depends on the stage (extent) of the cancer,its location in the colon, and the goal of the surgery. Some early coloncancers (stage 0 and some early stage I tumors) and most polyps can beremoved during a colonoscopy. However, if the cancer has progressed, alocal excision or colectomy, a surgical procedure that removes all orpart of the colon, may be required. In certain instances, nearby lymphnodes are also removed. A hemicolectomy, or partial colectomy, can beperformed if only part of the colon is removed. In a segmental resectionof the colon the surgeon removes the diseased part of the colon alongwith a small segment of non-diseased colon on either side. Usually,about one-fourth to one-third of the colon is removed, depending on thesize and location of the cancer. Major resections of the colon areillustrated in FIG. 26 , in which (i) A-B is a right hemicolectomy, A-Cis an extended right hemicolectomy, B-C is a transverse colectomy, C-Eis a left hemicolectomy, D-E is a sigmoid colectomy, D-F is an anteriorresection, D-G is a (ultra) low anterior resection, D-H is anabdomino-perineal resection, A-D is a subtotal colectomy, A-E is a totalcolectomy, and A-H is a total procto-colectomy. Once the resection iscomplete, the remaining intact sections of colon are then reattached.

During a laparoscopic-assisted colectomy procedure, it is oftendifficult to obtain an adequate operative field. Often times,dissections are made deep in the pelvis which makes it difficult toobtain adequate visualization of the area. As a result, the lower rectummust be lifted and rotated to gain access to the veins and arteriesaround both sides of the rectum during mobilization. During manipulationof the lower rectum, bunching of tissue and/or overstretching of tissuecan occur. Additionally, a tumor within the rectum can cause adhesionsin the surrounding pelvis, and as a result, this can require freeing therectal stump and mobilizing the mesentery and blood supply beforetransection and removal of the tumor.

After a colectomy, the remaining healthy portions of the colon must bereattached to one another to create a path for waste to leave the body.However, when using laparoscopic instruments to perform the colectomy,one single entry port device may not have a large enough range of motionto move the one end of the colon to connecting portion. As such, asecond entry port device is therefore needed to laparoscopically insertinstruments to help mobilize the colon and/or purchase the one end ofthe colon from a laparoscopic instrument of the first entry port deviceand move the one end to the connecting portion. The multiple portdevices having multiple instrument inserted therethrough to carry out atleast one surgical step or site can increase the chance of surgicalerrors and collisions between surgical instruments or robotic arms.

The present surgical systems include multiple port devices (e.g.,multi-port devices) that interconnect multiple groups of surgicalinstruments that can move together while also providing individualizedresistive inter-device forces and motions to the surgical instruments.For example, a first port device can be configured to receive a firstset of instruments (e.g., two or more instruments) and a second portdevice can be configured to receive a second set of instruments (e.g.,two or more instruments), and when at least one instrument from thefirst set and from the second set are inserted into the first and secondport devices, respectively, these instruments can move together as asingle group. Alternatively, or in addition, at least one insertedinstrument of the first set can move with at least one instrument of thesecond set, or vice versa.

FIG. 27 illustrates an exemplary embodiment a surgical system 8000 thatis configured to for laparoscopic and/or endoscopic access into a bodythrough two or more interconnected multi-port devices. FIG. 28schematically illustrates the surgical system 8000 being used in asurgical resection procedure on a colon 10. For purposes of simplicity,certain components of the surgical system 8000 are not illustrated.

As shown, the surgical system 8000 includes a first multi-port device8100 and a second multi-port device 8200, in which each multi-portdevice 8100, 8200 is configured to be at least partially disposed withinthe body. In other embodiments, the surgical system can include morethan two multi-port devices. It is also contemplated herein that inaddition to the multi-port devices, the surgical system can include oneor more single port devices.

The first multi-port device 8100 can have a variety of configurations.For example, in some embodiments, as shown in FIG. 27 and FIG. 28 , thefirst multi-port device 8100 includes a first housing 8101 with a firstport 8102 and a second port 8104 defined therein. The first and secondports 8102, 8104 are each configured to allow a respective surgicalinstrument to be inserted therethrough. For example, a first instrument8106 (shown in more detail in FIG. 28 ) can be inserted into the firstport 8102 and a second instrument 8108 (show in more detail in FIG. 28 )can be inserted into the second port 8104. The first and secondinstruments 8106, 8108 are collectively referred to herein as “a firstset of instruments.”

In use, the first multi-port device 8100 interacts with the firstinstrument 8106, the second instrument 8108, or both. The firstmulti-port device 8100 can be configured to interact with the firstinstrument 8106 and the second instrument 8108 concurrently, separately,or both. By way of example, the first multi-port device 8100 interactswith the first instrument 8106, and during the interaction, the firstmulti-port device 8100 applies resistive forces to the first instrument8106. These resistive forces limit one or more motions of the firstinstrument 8106 based on at least one of a location, orientation, and amotion of the second instrument 8108. A person skilled in the art willunderstand that the first multi-port device 8100 is configured to have asimilar interaction with the second instrument 8108.

The first housing 8101 can be formed of one or more suitablematerial(s). In some embodiments, a first portion of the first housingcan be formed of at least one first material and a second portion of thefirst housing can be formed of at least one second material. In suchembodiments, the first portion can be more flexible than the secondportion or vice versa. In other embodiments, the first housing isuniformly formed of one or more suitable material(s). A person skilledin the art will understand that the amount and type of resistive forcesthe first multi-port device applies to any inserted instrument willdepend at least upon the material(s) and structural configuration of thefirst housing and the amount of force and the direction of force appliedto the respective port by the inserted instrument.

The first and second ports 8102, 8104 can be configured to form a sealaround an instrument inserted therethrough. For example, a first sealingelement 8103 and a second sealing element 8105 can be positioned withinthe first port 8102 and the second port 8104, respectively. The sealingelements 8103, 8105 can be formed of any suitable material(s). A personskilled in the art will understand that the amount and type of resistiveforces the first multi-port device applies to any inserted instrumentwill depend at least upon the material(s) and structural configurationof any sealing element(s) disposed within the first and second ports ofthe first housing.

In use, the first and second sealing elements 8103, 8105 form a sealaround first and second instruments 8106, 8108, respectively. This canallow the physiological space inside the body to remain insufflated asthe first and second instruments 8106, 8108 and/or other suitableinstrument(s) are inserted and removed from the first multi-port device8100. In certain embodiments, one or more of the inserted instruments ofthe first multi-port device 8100 can pivotally move relative to thefirst housing 8101.

The second multi-port device 8200 can have a variety of configurations.For example, in some embodiments, as shown in FIG. 27 , the secondmulti-port device 8200 includes a second housing 8201 with a third port8202 and a fourth port 8204 defined therein. The third and fourth ports8202, 8204 are each configured to allow a respective instrument to beinserted therethrough. For example, a third instrument 8206 (shown inmore detail in FIG. 28 ) can be inserted into the third port 8202 and afourth instrument 8208 (shown in more detail in FIG. 28 ) can beinserted into the fourth port 8204. The third and fourth instruments8206, 8208 are collectively referred to herein as “a second set ofinstruments.”

In use, the second multi-port device 8200 interacts with the thirdinstrument 8206, the fourth instrument 8208, or both. The secondmulti-port device 8200 can be configured to interact with the thirdinstrument 8206 and the fourth instrument 8208 concurrently, separately,or both. By way of example, the second multi-port device 8200 caninteract with the third instrument 8206, and during this interaction,the second multi-port device 8200 applies resistive forces to the thirdinstrument 8206. These resistive forces limit one or more motions of thethird instrument 8206 based on at least one of a location, orientation,and a motion of the fourth instrument 8208. A person skilled in the artwill understand that the second multi-port device 8200 is configured tohave a similar interaction with the fourth instrument 8208.

The second housing 8201 can be formed of one or more suitablematerial(s). In some embodiments, a first portion of the second housingcan be formed of at least one first material and a second portion of thesecond housing can be formed of at least one second material. In suchembodiments, the first portion can be more flexible than the secondportion or vice versa. In other embodiments, the second housing isuniformly formed of one or more suitable material(s). A person skilledin the art will understand that the amount and type of resistive forcesthe second multi-port device applies to any inserted instrument willdepend at least upon the material(s) and structural configuration of thesecond housing and the amount of force and the direction of forceapplied to the respective port by the inserted instrument.

The third and fourth ports 8202, 8204 can be configured to form a sealaround an instrument inserted therethrough. For example, a third sealingelement 8203 and a fourth sealing element 8205 can be positioned withinthe third port 8202 and the fourth port 8204, respectively. The thirdand fourth sealing elements 8203, 8205 can be formed of any suitablematerial(s). A person skilled in the art will understand that the amountand type of resistive forces the second multi-port device applies to anyinserted instrument will depend at least upon the material(s) andstructural configuration of any sealing element(s) disposed within thethird and fourth ports of the second housing.

In use, the third and fourth sealing elements 8203, 8205 form a sealaround third and fourth instruments 8206, 8208, respectively. This canallow the physiological space inside the body to remain insufflated asthe third and fourth instruments 8206, 8208 and/or other suitableinstrument(s) are inserted and removed from the second multi-port device8200. In certain embodiments, one or more of the inserted instruments ofthe second multi-port device 8200 can pivotally move relative to thesecond housing 8201.

Further, the first multi-port device 8100 and/or the second multi-portdevice 8200 can incorporate various tracking mechanisms, such aselectromagnetic (EM) tracked tips, fiber bragg grating, various sensors,etc., to assist in tracking orientation, location, and movement of theinstruments. For example, the first multi-port device 8100 and thesecond multi-port device can include a first tracking device 8110 and asecond tracking device 8210, respectively. Each of the first and secondtracking devices 8110, 8210 can be configured to transmit a variety ofsignals that can be used to determine the relative location of the firstand second multi-port devices 8100, 8200, at least one of a location, anorientation, and a motion of at least one instrument inserted into oneof the first or second multi-port devices 8100, 8200 relative to theother one of the first or second multi-port devices 8100, 8200 orrelative to at least one instrument inserted into the other one of thefirst or second multi-port devices 8100, 8200, or a combination thereof.

In use, with respect to the first tracking device 8110, as the third andfourth instruments 8206, 8208 are inserted into the second multi-portdevice and moved within the body, the first tracking device 8110 isconfigured to transmit a first signal 8112 to a controller 8002 thatincludes sensed data associated with the third instrument 8206, thefourth instrument 8208, or the second set of instruments. That is, thefirst tracking device 8110 is configured to sense, or otherwise track,the third instrument 8206, the fourth instrument 8208, or both (e.g.,the second set of instruments), as such instrument(s) is/are insertedinto and moved in the body with or relative to the second multi-portdevice 8200. Alternatively, or in addition, the first signal 8112 or anadditional signal can include sensed data associated with the secondmulti-port device 8200. The first tracking device 8110 is alsoconfigured to transmit a second signal 8114 to the controller 8002 thatincludes sensed data associated with the first set of instruments and/orthe first multi-port device 8100 itself.

Once the first and second transmitted signals 8112, 8114 are transmittedto and received by the controller 8002, the controller 8002, based onthese signals, can calculate location, position, or motion of the thirdinstrument 8206, the fourth instrument 8208, or both, relative to thefirst set of instruments and/or the first multi-port device 8100 itself.This creates one or more interrelationships between the first and secondsets of instruments, and as a result, at least a portion of the firstand second sets of instruments can work cooperatively together at one ormore surgical sites and/or to carry out at least one surgical step of asurgical procedure. As shown in FIG. 28 , and as described in moredetail below, the first instrument 8106 and the third instrument 8206are working cooperatively together to handoff the free end 15 of thecolon 10, and the second instrument 8108 and the fourth instrument 8208are shown working cooperatively together to purchase the same area ofthe colon 10.

Similarly, with respect to the second tracking device 8210, in use, asthe first and second instruments 8106, 8108 are arranged within thebody, the second tracking device 8210 is configured to transmit a thirdsignal 8212 to the controller 8002 that includes sensed data associatedwith the first instrument 8106, the second instrument 8108, or the firstset of instruments. That is, the second tracking device 8210 isconfigured to sense, or otherwise track, the first instrument 8106, thesecond instrument 8108, or both (e.g., the first set of instruments), assuch instrument(s) is/are inserted into and moved within the body withor relative to the first multi-port device 8100. Alternatively, or inaddition, the third signal 8212 or an additional signal can includesensed data associated with the first multi-port device 8100. The secondtracking device 8210 is also configured to transmit a fourth signal 8214to the controller 8002 that includes sensed data associated with thesecond set of instruments and/or the second multi-port device 8200itself.

Once the third and fourth transmitted signals 8212, 8214 are transmittedto and received by the controller 8002, the controller 8002, based onthese signals, can calculate location, position, or motion of the firstinstrument 8106, the second instrument 8108, or both, relative to thesecond set of instruments and/or the second multi-port device 8200itself. This also creates one or more additional interrelationshipsbetween the first and second sets of instruments, and as a result, atleast a portion of the first and second sets of instruments can workcooperatively together at one or more surgical sites and/or to carry outat least one surgical step of a surgical procedure.

The tracking mechanism of the first and second tracking devices 8110,8210 can be any suitable mechanism. For example, the first trackingdevice 8110 can be configured to use magnetic sensing to detect alocation, an orientation, or a motion of the third instrument 8206, thefourth instrument 8208, or both relative to the first multi-port device8100 and/or to determine a location of the second multi-port device 8200relative to the first multi-port device 8100. In such instances, thethird instrument 8206, the fourth instrument 8208, or both and/or thesecond multi-port device 8200 includes a respective magnetic fiducialmarker (not shown) that is configured to emit a respective magneticfield that can be detected by the first tracking device 8110.Alternatively, or in addition, the second tracking device 8210 can beconfigured to use a similar magnetic sensing mechanism to detect alocation, an orientation, or a motion of at least one of the first andsecond instruments 8106, 8108 relative to the second multi-port device8200 and/or to determine a location of the first multi-port device 8100relative to the second multi-port device 8200. In some embodiment, amagnetic tracking system is configured to output a defined directionalfield relative to the magnet, its orientation, and near-by metallicsystems. When the magnet is a permanent magnet, the field is of apredefined intensity, size, and orientation. Since the field is vectordirectional, a magnetic sensor within the directional field isconfigured to sense from the intensity, direction of the magnet vectors,and change of those measures over time where the sensor is within thedirectional field and orientation of the sensor with respect to themagnet. When the magnet is an electro-magnet, the intensity and fielddirection can be alternated and changed as directed, which mitigatesmetal impacts on the field and interferences as well as increaseaccuracy. “DESIGN OF A MAGNETIC FIELD-BASED MULTI DEGREE-OF-FREEDOMORIENTATION SENSOR USING THE DISTRBUTED-MULTIPLE-POLE MODEL” fromProceedings of IMECE2007 2007 ASME International Mechanical EngineeringCongress and Exposition Nov. 11-15, 2007, Seattle, Wash., USAillustrates and describes multi-degree freedom magnetic field tracking.

For another example, the first tracking device 8110 can be configured touse common anatomic landmarks to detect a location, an orientation, or amotion of the third instrument 8206, the fourth instrument 8208, or bothrelative to the first multi-port device 8100 and/or a location of thesecond multi-port device 8200 relative to the first multi-port device8100. Alternatively, or in addition, the second tracking device 8210 canbe configured to use common anatomic landmarks to detect a location, anorientation, or a motion of at least one of the first and secondinstruments 8106, 8108 relative to the second multi-port device and/or alocation of the first multi-port device 8100 relative to the secondmulti-port device 8200. In some embodiments, the use of physiologiclandmarks, and the distances and focal aspects of these landmarks withrespect to an imaging system enable the imaging system to use the sameimaging and distance measurements to determine the location andorientation of the instruments with respect to the anatomic location.These “reference” points would enable the system to using imaging &pre-operative imaging to scale the measures allowing them to moreaccurately correct for focus or depth measures of the system. In certainembodiments, 3D imaging systems and/or Lidar imaging systems can both beused to enhance or replace the optical measurements with respect to thesurgical sites.

For yet another example, a structured light scan can be used to create a3D map. Electromagnetic tracking of the first multi-port device 8100,the second multi-port device 8200 and the instruments 8106, 8108, 8206,8208 (e.g., using one or more fiducial markers) provides 3D registrationof the map. A perimeter can then be created around a critical structureusing manual line or guides by confocal laser endomicroscopy to providereal time histology guidance. A line as registered in space can becommunicated to the first multi-port device 8100 and the first andsecond instruments 8106, 8108 located in a different quadrant of anabdominal cavity than the second multi-port device 8200 and third andfourth instruments 8206, 8208, for mobilizing the colon 10 between thequadrants. Alternatively, or in addition, a line as registered in spacecan be communicated to the second multi-port device 8200 and the thirdand fourth instruments 8206, 8208 for mobilizing the colon 10 betweenthe quadrants.

Alternatively, for yet another example, the physical mechanical linkageangles between robotic arms holding the surgical instruments and theirpredefined lengths can be used to enhance a visual system's calculationof depth and focal distance between surgical instruments and a surgicalsite. By using the linkage angles and predefined length, the system canachieve triangulation of the instruments within a patient in order to“calibrate” or compensate for optical losses by the imaging system.

For still another example, the first tracking device 8110 can be anoptical sensor that can be configured to detect a fiducial marker on thethird instrument, the fourth instrument, and/or the second multi-portdevice. Alternatively, or in addition, the second tracking device can bean optical sensor that is configured to detect a fiducial marker on thefirst instrument, the second instrument, and/or the first multi-portdevice. Any number of multi-ports and/or surgical instruments can betracked in this way during performance of a surgical procedure.

In some embodiments, controlling cooperative surgical instrumentinteractions includes using smart device location cooperatively withscope tracking. In general, a non-magnetic sensing system can be usedfor 3D tracking to provide X, Y, Z coordinates using a single receiverand at least one emitter. A time-of-flight distance sensor system,discussed above, may thus be used.

For example, the non-magnetic sensing system can include ultrasonicsensor technology and radiofrequency (RF) sensor technology. A time offlight system can include an emitter and a receiver. To facilitatecontrolling cooperative surgical imaging interactions, the emitterincludes an ultrasonic sensor (ultrasonic beacon) configured to transmitultrasonic pulses, and the receiver includes an RF receiver configuredto transmit an RF signal that commands the emitter to begin transmittingthe ultrasonic pulses. The ultrasonic pulses are reflected back byobject(s) within their range. The RF receiver is configured to recordthe ultrasonic pulses and to, based on the recorded ultrasonic pulses,calculate 3D coordinates (X, Y, Z) of the emitter. The sound propagationtime of the ultrasonic pulses allows the RF receiver to calculate the 3Dcoordinates and to calculate distance to objects.

FIG. 28 illustrates a schematic view of the surgical system 8000 beingused during a colon resection procedure. As explained above, the firsttracking device 8110 of the first multi-port device 8100 can track thethird instrument 8206, the fourth instrument 8208, or both, and thesecond tracking device 8210 of the second multi-port device 8200 cantrack the location of first instrument 8106, the second instrument 8108,or both, while the instruments are inserted into their respective portdevices and arranged within the body. Further, the first and secondinstruments 8106, 8108 can include first and second graspers 8107, 8109,respectively, and third and fourth instruments 8206, 8208 can includethird and fourth graspers 8207, 8209, respectively, to grasp the colon10 and the mobilized section 12 thereof and help reattach the mobilizedsection 12 to the rectum 14.

As shown in FIG. 28 , the first and second instruments 8106, 8108passing through the first multi-port device 8100 are arranged in theupper left quadrant of the abdominal cavity to mobilize the transverseand descending colon 10. The third and fourth instruments 8206, 8208passing through the second multi-port device 8200 are arranged in thelower left quadrant of the abdominal cavity to mobilize and create anincision along line IL to remove a tumor in the descending colon orsigmoid. Each set of instruments is accessing the abdominal cavitytogether through respective multi-port devices 8100, 8200, which allowfor interrelating the instrument motions for each multi-port within itsown quadrant. As illustrated, the first and second instruments 8106,8108 have a first range of motion shown as dashed line RA, and the thirdand fourth instruments 8206, 8208 have a second range of motion shown asdashed line RB.

Due to the location of the first and second multi-port devices 8100,8200 relative to each other and the resistive forces that are applied tothe respective first and second sets of instruments during use, there isan overlapping range of motion shown as OR in which both sets ofinstruments can move within. As a result, based on the overlapping rangeof motion relative to the position of the colon, the instruments 8106,8108, 8206, 8208 can interact during the handoff of the mobilization andretraction of the mobilized section 12 of the colon 10 transiting fromthe upper left quadrant to the lower right quadrant. Prior to and/orduring the handoff, the first tracking device 8110 transmits the firstand second signals 8112, 8114 to the controller 8002 and/or the secondtracking device 8210 transmits the third and fourth signals 8212, 8214to the controller 8002. The resulting interrelationship between thefirst and second multi-port devices 8100, 8200 (e.g., by way of thefirst and/or second tracking devices) enables triangulation and opposedmotion of the instruments 8106, 8108, 8206, 8208 within their respectivequadrant, as well as coordinated movement amongst at least a portion ofthe first and second set of instruments. As a result, the first andsecond sets of instruments work cooperatively together to interface witheach other to control and/or stabilize the colon, or a portion thereofand/or to move the free end 15 toward the rectum for attachment. Morespecifically, as shown in FIG. 28 , the second instrument 8108 and thefourth instrument 8208 are purchasing the same area of the colon 10, andthe third instrument 8206 is ready to grasp the free end 15 of the colon10 from the first instrument 8106 to move the free end 15 towards therectum 14.

Any one or more of the exemplary surgical systems, port devices andrelated methods described herein, and variations thereof, can beimplemented in conventional surgical procedures conducted by a medicalprofessional as well as in robotic-assisted surgical procedures. Variousteachings herein may be readily incorporated into a robotic surgicalsystem such as one or more of the DAVINCI™ systems by IntuitiveSurgical, Inc., of Sunnyvale, Calif., including their SP™ surgicalsystem. Exemplary robotic surgical systems and related features, whichmay be combined with any one or more of the exemplary surgical accessdevices and methods disclosed herein, are disclosed in the following:U.S. Pat. No. 8,068,649, entitled “Method and Apparatus for TransformingCoordinate Systems in a Telemanipulation System,” issued Nov. 29, 2011;U.S. Pat. No. 8,517,933, entitled “Retraction of Tissue for Single PortEntry, Robotically Assisted Medical Procedures,” issued Aug. 27, 2013;U.S. Pat. No. 8,545,515, entitled “Curved Cannula Surgical System,”issued Oct. 1, 2013; U.S. Pat. No. 8,551,115, entitled “Curved CannulaInstrument,” issued Oct. 8, 2013; U.S. Pat. No. 8,623,028, entitled“Surgical Port Feature,” issued Jan. 7, 2014, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,771,180, entitled“Retraction of Tissue for Single Port Entry, Robotically AssistedMedical Procedures,” issued Jul. 8, 2014, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,888,789, entitled“Curved Cannula Surgical System Control,” issued Nov. 18, 2014; U.S.Pat. No. 9,254,178, entitled “Curved Cannula Surgical System,” issuedFeb. 9, 2016; U.S. Pat. No. 9,283,050, entitled “Curved Cannula SurgicalSystem,” issued Mar. 15, 2016; U.S. Pat. No. 9,320,416, entitled“Surgical Instrument Control and Actuation,” issued Apr. 26, 2016, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.9,339,341, entitled “Direct Pull Surgical Gripper,” issued May 17, 2016;U.S. Pat. No. 9,358,074, entitled “Multi-Port Surgical Robotic SystemArchitecture,” issued Jun. 7, 2016; U.S. Pat. No. 9,572,481, entitled“Medical System with Multiple Operating Modes for Steering a MedicalInstrument Through Linked Body Passages,” issued Feb. 21, 2017; U.S.Pat. No. 9,636,186, entitled “Multi-User Medical Robotic System forCollaboration or Training in Minimally Invasive Surgical Procedures,”issued May 2, 2017; U.S. Pat. Pub. No. 2014/0066717, entitled “SurgicalPort Feature,” published Mar. 6, 2014, issued as U.S. Pat. No.10,245,069 on Apr. 2, 2019, the disclosure of which is incorporated byreference herein; U.S. Pat. Pub. No. 2017/0128041, entitled“Laparoscopic Ultrasound Robotic Surgical System,” published May 11,2017; and U.S. Pat. Pub. No. 2017/0128144, entitled “LaparoscopicUltrasound Robotic Surgical System,” published May 11, 2017, thedisclosure of which is incorporated by reference herein; and U.S. Pat.Pub. No. 2017/0128145, entitled “Laparoscopic Ultrasound RoboticSurgical System,” published May 11, 2017. The disclosure of each ofthese references is incorporated by reference herein.

Surgical Sealing Systems for Instrument Stabilization

In various surgical procedures, a surgeon may need to direct two or moresurgical instruments into a body cavity simultaneously in order to gainaccess to and provide effective treatment to tissue. It is generallydesirable, however, to minimize the number of surgical openings thatneed to be formed in the patient (e.g., in a patient's abdominal wall)to thereby mitigate tissue trauma, cosmetic damage, and post-operationrecovery time for the patient. Accordingly, surgical sealing systems areprovided that generally include a sealing device having a seal housingwith ports for receiving surgical instruments.

In general, the ports of the seal housing are designed to control orlimit the motions of at least one instrument inserted through arespective port such that the instrument can stabilize anotherinstrument inserted through a respective other port. Each of the portscan have a nominal size and shape and each can be configured to assume aselected size and/or shape that is different from the nominal sizeand/or shape. A person skilled in the art will understand that a nominalsize and a nominal shape refer to a size and shape of a port without aforce applied thereto. Similarly, a person skilled in the art willunderstand that a selected size and a selected shape of a port refers toa size and shape of a port when a force is applied to the port, such asby an instrument being inserted therethrough. It will be furtherunderstood by a person skilled in the art that the selected size and theselected shape will depend on the amount of force and the direction offorce applied to the port, such as by the instrument.

The selected size and/or shape of each port can be constrained by thesize and shape of each of the other plurality of ports. As a result,forces applied to one port can affect the size and shape of the otherports. The force can be applied by an instrument that is disposed withinone port of the plurality of ports. The force applied thereto istherefore effective to change the size and/or shape of the ports basedon the movement, direction, and force of the instrument. Since theability to alter to the nominal shape of any one port is thereforeconstrained or limited by the size and/or shape of the other ports, aforce applied to one instrument positioned within one of the pluralityof ports is configured to stabilize at least one other instrumentpositioned within others of the plurality of ports.

FIG. 29 and FIG. 30 illustrate a surgical sealing device 9000 thatincludes a seal housing 9002 with a predetermined size and shape andports 9008, 9010, 9012, 9014 extending therethrough before any externalforce is applied to the ports. As shown in FIG. 29 and FIG. 30 , theseal housing 9002 is illustrated in its predetermined size and shape.The seal housing 9002 can have a variety of configurations. For example,in this illustrated embodiment, the seal housing 9002 has an inner bodymember 9004 and an outer body member 9005 that is positioned about theinner body member 9004. In certain embodiments, the inner body member9004 can be flexible relative to the outer body member 9005 or viceversa. Stated differently, the outer body member 9005 can be rigidrelative to the inner body member 9004 or vice versa. In one embodiment,the inner body member and the outer body member are formed of the samematerial.

While any number of ports can be formed in the seal housing 9002, inthis illustrated embodiment, four ports 9008, 9010, 9012, 9014 extendthrough sealing housing 9002. The ports can be formed in any suitableportion(s) of the seal housing 9002. For example, as shown in FIG. 29and FIG. 30 , all the ports 9008, 9010, 9012, 9014 extend through theinner body member 9004 of the seal housing 9002. Further, the ports9008, 9010, 9012, 9014 can be movable with respect to the seal housing9002 and each other, as discussed in more detail below. Such aconfiguration can help prevent interference between surgical instrumentsinserted through the various ports 9008, 9010, 9012, 9014 and canfacilitate instrument positioning in a body cavity to which the surgicalsealing device 9000 provides access thereto.

In some embodiments, as shown in FIG. 29 and FIG. 30 , the sealingdevice 9000 can include a retractor 9006 that couples to and extendsfrom a distal end 9002d of the seal housing 9002. The retractor 9006 canbe configured to be placed in any opening within a patient's body,whether a natural body orifice or an opening made by an incision. Assuch, the retractor 9006 can function as a support structure for theseal housing 9002 and form a pathway through the opening in a patient'sbody so that surgical instruments can be inserted through the ports9008, 9010, 9012, 9014 and into the interior body cavity or natural bodylumen of the patient. Further, the retractor can additionally functionas a retention element that is configured to affix the seal housing totissue. In certain embodiments, in order to secure the seal housingwithin an incision or natural body orifice, a separate retention element9007 can be used arranged on the exterior surface of retractor 9006, asshown in FIG. 29 , and/or the exterior surface of the seal housing 9100.

The ports 9008, 9010, 9012, 9014 can be configured to form a seal arounda surgical instrument inserted therethrough. For example, in someembodiments, at least one or more of the ports can include a sealingelement, which can be positioned within the channel of the respectiveport. A sealing element can include at least one instrument seal and/orat least one channel seal, and can generally be configured to contact aninstrument inserted through the sealing element's associated sealingport. For example, the port 9012 can include a sealing element 9021arranged within the channel 9013 of the port 9012, and the port 9014 caninclude a sealing element 9023 arranged within the channel 9015 of theport 9014. While not illustrated, a person skilled in the art willappreciate that one or more of the other ports can include a sealingelement (e.g., sealing element(s) structurally similarly to sealingelements 9021, 9023).

In some embodiments, the sealing element(s) can be in the form of a thinmembrane formed of a flexible material which can be punctured orotherwise pierced by a surgical instrument. In addition, oralternatively, zero closure sealing elements such as a duck bill seal orother suitable seals for sealing in the absence of instrument can beused in association with the ports. The sealing elements can bepositioned at any suitable location within the port.

The surgical sealing device 9000 can also include an insufflation port9016 supported by the seal housing 9002, although a person skilled inthe art will appreciate that the insufflation port 9016 can be locatedin other locations. A person skilled in the art will also appreciatethat the insufflation port 9016 can have a variety of configurations.Generally, the insufflation port 9016 can be configured to pass aninsufflation fluid into and/or out of a body cavity to which thesurgical sealing device 9000 provides access to.

FIG. 31 and FIG. 32 are schematic bottom views of the surgical sealingdevice 9000 with the retractor 9006 and the sealing elements 9021, 9023removed. As stated above, the ports 9008, 9010, 9012, 9014 can have anycombination of sizes and shapes. The port 9008 can have a diameter D1,port 9010 can have a diameter D2, and ports 9012, 9014 can have adiameter D3. The insufflation port opening 9016 can have any diameterD4. The diameter D3 of the ports 9012, 9014 can define a diameter of anorbital path of instruments arranged within the ports 9012, 9014.

When an instrument is inserted into one of the ports 9008, 9010, 9012,9014, and a force is applied to the instrument, the port can adjust froma nominal size and shape to a selected size and shape based on themovement, direction, and force of the instrument. As shown in FIG. 31 ,the ports 9012, 9014 can include a nominal shape 9018, 9020,respectively. The nominal shape 9018, 9020 of the ports 9012, 9014 isthe size and shape of the ports when no instrument is arranged thereinand applying a force to the ports. Additionally, the port 9008 has anominal size and shape 9009 when no instrument is arranged therein. Incertain embodiments, the seal housing 9100 can have a diameter D5, whichcan be fixed or adjustable.

Each of the plurality of ports 9012, 9014 has a nominal size and shape9018, 9020 and diameter D3, and each is configured to assume a selectedsize and/or shape 9018′, 9020′ that is different from the nominal sizeand shape 9018, 9020, wherein the selected size and/or shape 9018′,9020′ of each port is constrained by the size and shape of each of theother plurality of ports. Additionally, the altered diameter D3′ of theports 9012, 9014 can further limit the planes in which an instrument canmove. For example, as shown in FIG. 32 , the ports 9012, 9014 havebecome narrower and oval shape, limiting an instrument within the portsto only be moveable in plane parallel to the diameter D3′ of each port9012, 9014. Since the limiting planes for ports 9012, 9014 arenon-parallel, the instruments within the ports 9012, 9014 can be used tostabilize a third instrument within the port 9010.

An example of how the ports 9008, 9012, 9014 are altered from theirnominal size and shapes 9009, 9018, 9020 to their selected size andshapes 9009′, 9018′, 9020′ is as follows. An instrument (not shown) isinserted into each respective port 9008, 9010, 9012, 9014 parallel tothe Y-axis. As the instrument arranged within the port 9008 is pivotedalong the X-axis, the port 9008 changes from a nominal size and shape9009 to a selected size and shape 9009′ as a result of the instrumentapplying a force to the port 9008, causing the port 9008 react andchange to an elongated shape along the X-axis. As the port 9008 is inthe selected size and shape 9009′, the instrument in the port 9012 canbe moved along the Z-axis. However, due to the port 9008 already beingelongated along the X-axis, the port 9012 will change from the nominalsize and shape 9018 to the selected size and shape 9018′. As illustratedin FIG. 32 , the port 9012 becomes elongated at an approximately 45°angle from the Z-axis, which was the intended axis of travel for theinstrument. If the port 9008 was not in the selected size and shape9009′, then the selected size and shape of the port 9012 can be parallelto the Z-axis since the port 9008 would not be blocking the movement ofthe port 9012.

Additionally, the port 9014 operates similarly to the port 9012 wherethe intended direction of an instrument within the port 9014 is parallelto the Z-axis. However, similar to the port 9012, the selected size andshape 9020′ of the port 9014 is limited by the selected size and shape9009′ of the port 9008. This forces the port 9014 to elongate atapproximately a 135° angle relative to the Z-axis when moving from thenominal size and shape 9020 to the selected size and shape 9020′.

In certain embodiments, if the selected size and shape 9018′ of the port9012 was instead parallel to the X-axis, and the selected size and shape9009′ of the port 9008 remained parallel to the X-axis, then theselected size and shape of the port 9014 would be limited to moving onlyin the +Z axis and the +X-axis since the −Z axis would be blocked by theport 9008 and the −X-axis would be blocked by the port 9012.

In some embodiments, the sealing device can include restraining elementsthat can further control some but not all the movements and forces ofthe instruments inserted into the sealing device. For example, as shownin FIG. 30 , port 9010 can includes a rigid structure 9011 encapsulatedby the inner body member 9004. In other embodiments, one or more portscan include rigid restraining elements while one or more other ports caninclude flexible restraining elements that allows some movement inpredefined directions of the ports with respect to each other whilepreventing other movements. In certain embodiments, the seal housingincludes restraining features positioned in at least some directionstangential to the ports to substantially prevent stretching or movementof one port relative to another. This can be done in multiple planes forthe same port or in selective directions to allow the port to float inother directions to improve maintenance of the seal around theinstrument being inserted through the sealing device.

In certain embodiments, one of the inserted instruments within one ofthe ports of the seal housing can function as a central anchoring tool.The central anchoring tool can be a designated instrument within one ofthe ports of the seal housing which supports the remaining instrumentspassing through other ports within the seal housing. In someembodiments, the central anchoring tool can be an instrument that doesnot interact with tissue directly, such as a camera or scope devicepassing through a port. Alternatively, the central anchoring tool can bean instrument (e.g., graspers, electrosurgical tool, etc.) thatinteracts with the tissue so that the additional instruments can bemanipulated and supported without altering the anchor point of the sealhousing. FIG. 33 illustrates an exemplary central anchor tool 9017inserted into port 9014 of sealing device 9000.

In certain embodiments, at least one of the ports can include a threadedrestraint arranged within a respective port, for example, as illustratedin FIG. 34 . Aside from the differences described in detail below,sealing device 9200 can be similar to sealing device 9000 (FIG. 29 ) andtherefore common features are not described in detail herein. As shown afirst threaded restraint 9202 is configured to be arranged in a firstport 9204 and a second threaded restraint 9206 is configured to bearranged in second port 9208. Each threaded restraint 9202, 9206 isconfigured to fixate an instrument arranged within each respective port9204, 9208 to the seal housing 9209 and each of the threaded restraints9202, 9206 is configured to contact the outer surface of the instrument.While the threaded restraints 9202, 9206 can have a variety ofconfigurations, in this illustrated embodiment, each of the first andsecond threaded restraints 9202, 9206 includes a generally cylindricalbody 9210, 9212 with threads 9214, 9216 on its outer surface 9218, 9219.The threads 9214, 9216 are configured to threadably engage correspondingthreads 9220, 9222 on each respective first and second ports 9204, 9208.

During use, as an instrument is inserted into and rotated within thefirst port 9204 or the second port 9208, the respective first or secondthreaded restraint 9202, 9206 also rotates, thereby tightening therespective first or second threaded restraint 9202, 9206 relative to theseal housing 9209. As the threaded restraint 9202, 9206 tightens, therange of motion available to the inserted instrument decreases. Once thethreaded restraint 9202, 9206 is fully tightened, the instrument isfixated to the seal housing 9209. While fixated, the instrument canserve as an anchor for the other instruments within the other ports9204, 9208 of the seal housing 9209.

In other embodiments, the sealing systems can include integratedmechanism or electronic activated restriction systems to provideselective support or floating (e.g., moving) operation. For example, afluidic coupling cylinder with a selectively sizeable valve can beemployed on or in the seal housing to inhibit motion. In certainembodiments, a solenoid valve can be used to inhibit circular fluidmotion.

In some embodiments, the ports can be configured to change shape andsize in response to an external energy being applied to the ports. Forexample, each of the plurality of ports 9012, 9014 can be formed of aferromagnetic material that is configured to be structurally altered inresponse to exposure to an electromagnet. During use, the electromagnetcan apply a magnetic flux to the ports 9012, 9014 to cause the ports9012, 9014 to alter their at least their shape compared to their shapewhen the electromagnet is switched off.

Any one or more of the exemplary surgical sealing systems, devices andrelated methods described herein, and variations thereof, can beimplemented in conventional surgical procedures conducted by a medicalprofessional as well as in robotic-assisted surgical procedures. Variousteachings herein may be readily incorporated into a robotic surgicalsystem such as one or more of the DAVINCI™ systems by IntuitiveSurgical, Inc., of Sunnyvale, Calif., including their SP™ surgicalsystem. Exemplary robotic surgical systems and related features, whichmay be combined with any one or more of the exemplary surgical accessdevices and methods disclosed herein, are disclosed in the following:U.S. Pat. No. 8,068,649, entitled “Method and Apparatus for TransformingCoordinate Systems in a Telemanipulation System,” issued Nov. 29, 2011;U.S. Pat. No. 8,517,933, entitled “Retraction of Tissue for Single PortEntry, Robotically Assisted Medical Procedures,” issued Aug. 27, 2013;U.S. Pat. No. 8,545,515, entitled “Curved Cannula Surgical System,”issued Oct. 1, 2013; U.S. Pat. No. 8,551,115, entitled “Curved CannulaInstrument,” issued Oct. 8, 2013; U.S. Pat. No. 8,623,028, entitled“Surgical Port Feature,” issued Jan. 7, 2014, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,771,180, entitled“Retraction of Tissue for Single Port Entry, Robotically AssistedMedical Procedures,” issued Jul. 8, 2014, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,888,789, entitled“Curved Cannula Surgical System Control,” issued Nov. 18, 2014; U.S.Pat. No. 9,254,178, entitled “Curved Cannula Surgical System,” issuedFeb. 9, 2016; U.S. Pat. No. 9,283,050, entitled “Curved Cannula SurgicalSystem,” issued Mar. 15, 2016; U.S. Pat. No. 9,320,416, entitled“Surgical Instrument Control and Actuation,” issued Apr. 26, 2016, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.9,339,341, entitled “Direct Pull Surgical Gripper,” issued May 17, 2016;U.S. Pat. No. 9,358,074, entitled “Multi-Port Surgical Robotic SystemArchitecture,” issued Jun. 7, 2016; U.S. Pat. No. 9,572,481, entitled“Medical System with Multiple Operating Modes for Steering a MedicalInstrument Through Linked Body Passages,” issued Feb. 21, 2017; U.S.Pat. No. 9,636,186, entitled “Multi-User Medical Robotic System forCollaboration or Training in Minimally Invasive Surgical Procedures,”issued May 2, 2017; U.S. Pat. Pub. No. 2014/0066717, entitled “SurgicalPort Feature,” published Mar. 6, 2014, issued as U.S. Pat. No.10,245,069 on Apr. 2, 2019, the disclosure of which is incorporated byreference herein; U.S. Pat. Pub. No. 2017/0128041, entitled“Laparoscopic Ultrasound Robotic Surgical System,” published May 11,2017; and U.S. Pat. Pub. No. 2017/0128144, entitled “LaparoscopicUltrasound Robotic Surgical System,” published May 11, 2017, thedisclosure of which is incorporated by reference herein; and U.S. Pat.Pub. No. 2017/0128145, entitled “Laparoscopic Ultrasound RoboticSurgical System,” published May 11, 2017. The disclosure of each ofthese references is incorporated by reference herein.

FIG. 35 illustrates an exemplary embodiment of two robotic arms 9300,9302, each having a surgical instrument 9304, 9306 attached thereto. Therobotic arms 9300, 9302 can be wirelessly coupled to a control system9308 having a console, with a display 9310, a controller 9312, and auser input device 9314. As shown, seal housing 9316 is partiallyinserted into a patient's body 9318, and each surgical instrument 9304,9306 is inserted into a respective port 9320, 9322 of the seal housing9316. In certain embodiment, the robotic arm(s) 9300, 9302 can beconfigured to create a compression loading around the ports to theprevent motion of the surgical instruments 9304, 9306.

In some embodiments, the controller 9312 is configured to receive aforce reading from at least one of the plurality of ports 9008, 9010,9012, 9014 (see FIG. 32 ) based on the movement, direction, and force ofan instrument. For example, a force sensor (not shown) can be arrangedon each robotic arm 9300, 9302 such that the force applied by each armcan be measured and sent to the controller 9312. Based on the measuredforce readings, the controller 9312 can determine a selected size andshape 9018′, 9020′ of ports 9012, 9014 (see FIG. 32 ) based on theamount of force the inserted instruments 9304, 9306 is applying to suchports 9012, 9014. Based on the determined selected size and shape 9018′,9020′, the robotic arm(s) 9300, 9302 can be moved by the user in such away that can alter the size and shape of the ports 9012, 9014 tostabilize at least one other instrument (not shown) positioned within atleast one of the other ports 9008, 9010.

In certain embodiments, a tool driver restraint of a trocar access portcan be used in combination with the surgical sealing device 9000. Thetrocar access port can be used to limit the force applied to aninstrument shaft, allowing for a robotic arm to control the forces. Therobotic arm restraint of the trocar access port can be used to allow thetool driver restraint to provide a stabilizing force to the surgicalsealing device 9000, and not instruments inserted through the ports. Inthis embodiment, the diameter of the trocar access port is the keyrigidity factor, rather than the diameter D5 of the surgical sealingdevice 9000. In certain embodiments, a cannula from which multipleinstruments are deployed from does not have a static end lumen. Instead,the cannula is segmented into two or more curved members. The curvedmembers can be driven to different depths within tissue to provide for alocal force reaction to the instrument that is against that respectivecannula segment.

In certain embodiments, one of the ports can further include a lockingarm configured to lock a position of the at least one port relative tothe seal housing. FIG. 36 illustrates an exemplary embodiment of a sealhousing 9402 having a slot 9403 arranged therein such that a locking arm9404 can pass through the slot 9403 and into the seal housing 9402. Asshown, the locking arm 9404 include locking tabs 9406, which areconfigured to be selectively depressed to allow the locking arm 9405 tomove relative to the seal housing 9402. Arranged at a distal end of thelocking arm 9404 is a port 9412, with an instrument 9410 arranged withinthe port 9412. Due to the arrangement of the locking arm 9404, the port9412 can be moved relative to the seal housing 9402. Other suitableconfigurations of a locking arm are also contemplated herein. Forexample, another configuration of the locking arm can include a basemember having a plurality of rotatable rings. A top rotatable ring cancontain a flexible sealing member, and one or more other rotatable ringseach can have sealing arms extending therefrom and can be stacked one ontop of the other beneath the sealing member. Each ring can beindividually rotatable relative to the other rings and relative to thesealing member. Each of the sealing arms can include a sealing elementpositioned at one end thereof and configured to form a seal around aninstrument inserted therethrough.

FIG. 37 and FIG. 38 illustrate an exemplary embodiment of a locking seal9500 arranged within at least one port 9502 of a seal housing 9504. Thelocking seal 9500 can be in the form of a honeycomb locking structurewhich interacts with an instrument 9510 passing therethrough. The shapeof the locking seal 9500 can be adjusted through the application ofexternal energy, such as heat, light, or electrical current. Asillustrated in FIG. 38 , after exposure to external energy, the lockingseal 9500 can deform into a first portion 9506 and a second portion9508. When deformed, the second portion 9508 can contact the instrument9510 so that the instrument 9510 is locked in position to the sealhousing 9504.

In certain embodiments, a surgical sealing device can further includechangeable ports as restraining means to control some, but not allmovements and forces of instruments inserted therethrough the ports ofthe surgical sealing device. The ports of the surgical sealing devicecan include sections that are formed from 4D printed material and thenover molded into an elastomer section of a seal with a port. 4D printingis an additive manufacturing process through which a 3D printed objectincludes transformable components (e.g., hydrogel, shape memory polymer)such that the 3D printed object transforms itself into another structureover the influence of external energy input as temperature, light orother environmental stimuli. 4D printing is similar to 3D printing inthe sense that an object is also built layer by layer, but the objectcan then change over time after its initial manufacture. The object willchange because it is printed with materials that have the ability tochange when exposed to certain factors: such as heat, magnetic, water,light or another source of energy.

In some embodiments, the ports including a 4D printed material initiallycan be in a flexible condition to allow for introduction andmanipulation of instruments through the ports. At defined conditions,the surgical sealing device can have an external energy applied theretoto alter the structure of the 4D printed material thus changing thegeometry of the seal interface with respect to the instrument and/orlock to the seal itself. Additionally, the 4D printed material caninterlock all the ports of a surgical sealing device and instrumentsinserted therein to create rigid restraints allowing some movement ofthe instruments in predefined directions with respect to each otherwhile preventing some movements of the instruments in other directions.The prevention of movement in some directions allows for an instrumentinteracting with the 4D printed material to stabilize the otherinstruments within the surgical sealing device.

An example of how a 4D printed material would interact with aninstrument within a port is as follows. A honeycomb structure can beformed of 4D printed material and integrated with the pivotal sealswithin each of the ports of the surgical sealing device. The honeycombstructure can be in a triangular or hexagonal pattern that allows aninstrument shaft to freely pass through the seal. When needed oractivated by heat, pressure, light or an energy source, the honeycombstructure alters its form for to make contact with the instrument shaft.Contact is made by the triangular or hexagonal honeycomb bending inwardtowards the instrument shaft, compressing the honeycomb structure and/orseal material against the shaft.

In certain embodiments, the surgical sealing device can include a 3Dprinted housing support structure having an elastomer structural member.The elastomer structural member can be pneumatically actuated between afix and no fixed state in order to fixate instrument inserted throughthe ports of the surgical sealing system.

The surgical devices disclosed herein can be designed to be disposed ofafter a single use, or they can be designed to be used multiple times.In either case, however, the surgical devices can be reconditioned forreuse after at least one use. Reconditioning can include any combinationof the steps of disassembly of the surgical devices, followed bycleaning or replacement of particular pieces and subsequent reassembly.In particular, the surgical devices can be disassembled, and any numberof the particular pieces or parts of the surgical devices can beselectively replaced or removed in any combination. Upon cleaning and/orreplacement of particular parts, the surgical devices can be reassembledfor subsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a surgical device can utilize avariety of techniques for disassembly, cleaning/replacement, andreassembly. Use of such techniques, and the resulting reconditionedinstrument, are all within the scope of the present application.

Further, in the present disclosure, like-named components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-named component is notnecessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. Sizes and shapes ofthe systems and devices, and the components thereof, can depend at leaston the anatomy of the subject in which the systems and devices will beused, the size and shape of components with which the systems anddevices will be used, and the methods and procedures in which thesystems and devices will be used.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a user, such as a clinician, gripping a handleof an instrument. It will be appreciated that the terms “proximal” and“distal” are used herein, respectively, with reference to the top end(e.g., the end that is farthest away from the surgical site during use)and the bottom end (e.g., the end that is closest to the surgical siteduring use) of a surgical instrument, respectively, that is configuredto be mounted to a robot. Other spatial terms such as “front” and “rear”similarly correspond respectively to distal and proximal. It will befurther appreciated that for convenience and clarity, spatial terms suchas “vertical” and “horizontal” are used herein with respect to thedrawings. However, surgical instruments are used in many orientationsand positions, and these spatial terms are not intended to be limitingand absolute.

Values or ranges may be expressed herein as “about” and/or from/of“about” one particular value to another particular value. When suchvalues or ranges are expressed, other embodiments disclosed include thespecific value recited and/or from/of the one particular value toanother particular value. Similarly, when values are expressed asapproximations, by the use of antecedent “about,” it will be understoodthat here are a number of values disclosed therein, and that theparticular value forms another embodiment. It will be further understoodthat there are a number of values disclosed therein, and that each valueis also herein disclosed as “about” that particular value in addition tothe value itself. In embodiments, “about” can be used to mean, forexample, within 10% of the recited value, within 5% of the recited valueor within 2% of the recited value.

For purposes of describing and defining the present teachings, it isnoted that unless indicated otherwise, the term “substantially” isutilized herein to represent the inherent degree of uncertainty that maybe attributed to any quantitative comparison, value, measurement, orother representation. The term “substantially” is also utilized hereinto represent the degree by which a quantitative representation may varyfrom a stated reference without resulting in a change in the basicfunction of the subject matter at issue.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety. Any patent, publication, orinformation, in whole or in part, that is said to be incorporated byreference herein is only to the extent that the incorporated materialdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this document. As such the disclosureas explicitly set forth herein supersedes any conflicting materialincorporated herein by reference.

What is claimed is:
 1. A surgical sealing system, comprising: a sealingdevice having a seal housing with a predetermined size and shape, theseal housing being configured to be at least partially disposed within abody cavity and having a plurality of ports; wherein each of theplurality of ports has a nominal size and shape and each is configuredto assume a selected size and/or shape that is different from thenominal size and/or shape, the selected size and/or shape of each portbeing constrained by the size and shape of each of the other pluralityof ports; wherein each of the plurality of ports is configured to form aseal around an instrument inserted therethrough; and wherein theposition of an instrument that is positioned within one port of theplurality of ports and a force applied thereto is effective to changethe size and/or shape of the ports based on the movement, direction, andforce of the instrument, and the ability to alter the nominal shape ofany one port is constrained or limited by the size and/or shape of theother ports, thereby enabling a force applied to one instrumentpositioned within one of the plurality of ports to stabilize at leastone other instrument positioned within others of the plurality of ports.2. The surgical sealing system of claim 1, further comprising at leastone electromechanical arm, and wherein at least one instrument that isinserted into a respective port of the plurality of ports is connectedto the at least one electromechanical arm.
 3. The surgical sealingsystem of claim 1, wherein a first port of the plurality of ports isconfigured to apply a first force to a first instrument that is insertedtherethrough to thereby limit movement thereof within a first plane, anda second port of the plurality of ports is configured to apply a secondforce to a second instrument that is inserted therethrough to therebylimit movement thereof within a second plane, the second plane beingnon-parallel to the first plane.
 4. The surgical sealing system of claim1, wherein at least one port of the plurality of ports includes athreaded restraint configured to fixate an instrument insertedtherethrough.
 5. The surgical sealing system of claim 1, wherein a firstinstrument and a second instrument that are inserted into respectiveports of the plurality of ports are stabilized simultaneously by acentral anchoring tool that is configured to be inserted through a portof the plurality of ports.
 6. The surgical system of claim 1, whereinone or more ports of the plurality of ports are rigid relative to one ormore other ports of the plurality of ports.
 7. The surgical sealingsystem of claim 1, wherein at least one port of the plurality of portsis configured to change shape and size in response to external energybeing applied thereto.
 8. The surgical sealing system of claim 1,wherein at least one port of the plurality of ports is formed of aferromagnetic material that is configured to be structurally altered inresponse to exposure to an electromagnet.
 9. The surgical sealing systemof claim 1, wherein at least one port of the plurality of ports includesa locking arm arranged within a slot of the seal housing, the lockingarm being configured to lock a position of the at least one portrelative to the seal housing.
 10. The surgical sealing system of claim1, wherein the sealing housing further comprises a flexible inner bodymember and a rigid outer body member, wherein each port of the pluralityof ports is arranged within the inner body member.
 11. The surgicalsealing system of claim 10, wherein at least one port of the pluralityof ports includes a rigid ring encapsulated by the flexible inner bodymember.
 12. The surgical sealing system of claim 1, wherein at least oneport of the plurality of ports includes a locking structure that isconfigured to interact and collapse around an instrument passingtherethrough to fixate the inserted instrument within the at least oneport.
 13. The surgical sealing system of claim 12, wherein the lockingstructure has a honeycomb configuration.
 14. The surgical sealing systemof claim 1, wherein the sealing device comprises a retractor that iscoupled to the seal housing and configured to be positioned in a naturalbody orifice or an opening formed in tissue.
 15. The surgical sealingsystem of claim 1, wherein the sealing device comprises at least oneretention element that is configured to affix the seal housing totissue.